Publications by authors named "Annamaria Colao"

649 Publications

Ketogenic diet: a tool for the management of neuroendocrine neoplasms?

Crit Rev Food Sci Nutr 2020 Oct 14:1-11. Epub 2020 Oct 14.

Department of Experimental Medicine, University of Rome "La Sapienza," Rome, Italy.

Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms, whose incidence has rapidly increased in the last years. Nutrition plays an important role in their management; indeed, malnutrition negatively impacts on rates of complications, hospitalization, hospital stay, costs and mortality. Furthermore, it has been reported that a poor nutritional status could influence the outcome of patients with pancreatic NENs. Moreover, obesity, predisposing to insulin resistance and compensatory hyperinsulinemia, could stimulate the growth of these neoplasms. Ketogenic diet (KD), a high-fat, low-carbohydrate diet with adequate amounts of protein, has been reported to be a promising approach for the management of several types of cancer, mostly gynecological and neurological ones. Indeed, it appears to sensitize most cancers to standard treatment by exploiting the reprogramed metabolism of cancer cells and thus resulting in a promising candidate as an adjuvant cancer therapy. Thus, the aim of this review is to provide an overview on the importance of nutrition in cancer management and in particular in NENs' setting. Furthermore, we reported the current evidence on the efficacy of KD in the management of cancer and based on molecular mechanisms; we also hypothesize the potential use of this nutritional pattern in the management of NENs.
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http://dx.doi.org/10.1080/10408398.2020.1832955DOI Listing
October 2020

Immune Checkpoint Inhibitors: New Weapons Against Medullary Thyroid Cancer?

Front Endocrinol (Lausanne) 2021 14;12:667784. Epub 2021 Apr 14.

Endocrinology Unit, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.

Medullary thyroid carcinoma is a rare neuroendocrine neoplasm that originates from thyroid C cells. Surgery, with complete resection of the tumor, is the only curative approach. However, in most cases, the tumor recurs at locoregional or metastatic level. In this setting, the management remains challenging. In recent years, the immune checkpoint inhibitors have provided promise for changing the cancer treatment paradigm through the application of new approaches that enhance the body's natural antitumor defenses. The aim of this review is to summarize and discuss available data on efficacy and safety of the Food and Drug Administration-approved immune checkpoint inhibitors in patients with medullary thyroid carcinoma. After an extensive search, we found 7 useful data sources (one single-case report, one short article with very preliminary data, five ongoing registered clinical trials). Despite the lack of published evidence regarding the use of immune check point inhibitors, it must be considered that all the ongoing registered clinical trials saw first light in the last three years, thus indicating a growing interest of researchers in this field. Results coming from these trials, and hopefully, in the next future, from additional trials, will help to clarify whether this class of drugs may represent a new weapon in favor of patients with medullary thyroid carcinoma.
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http://dx.doi.org/10.3389/fendo.2021.667784DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081349PMC
April 2021

Role of FGF System in Neuroendocrine Neoplasms: Potential Therapeutic Applications.

Front Endocrinol (Lausanne) 2021 14;12:665631. Epub 2021 Apr 14.

Department of Clinical Medicine and Surgery, Federico II University of Naples, Naples, Italy.

Neuroendocrine neoplasms (NENs) are a heterogeneous group of tumors originating from neuroendocrine cells dispersed in different organs. Receptor tyrosine kinases are a subclass of tyrosine kinases with a relevant role in several cellular processes including proliferation, differentiation, motility and metabolism. Dysregulation of these receptors is involved in neoplastic development and progression for several tumors, including NENs. In this review, we provide an overview concerning the role of the fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) system in the development and progression of NENs, the occurrence of fibrotic complications and the onset of drug-resistance. Although no specific FGFR kinase inhibitors have been evaluated in NENs, several clinical trials on multitarget tyrosine kinase inhibitors, acting also on FGF system, showed promising anti-tumor activity with an acceptable and manageable safety profile in patients with advanced NENs. Future studies will need to confirm these issues, particularly with the development of new tyrosine kinase inhibitors highly selective for FGFR.
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http://dx.doi.org/10.3389/fendo.2021.665631DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080021PMC
April 2021

Phase Angle as an Easy Diagnostic Tool of Meta-Inflammation for the Nutritionist.

Nutrients 2021 Apr 24;13(5). Epub 2021 Apr 24.

Centro Italiano per la Cura e il Benessere del Paziente con Obesità (C.I.B.O), Endocrinology Unit, Department of Clinical Medicine and Surgery, University Medical School of Naples, Via Sergio Pansini 5, 80131 Naples, Italy.

Phase angle (PhA), a noninvasive bioimpedance marker, is a useful tool for nutritional screening in several diseases. C-reactive protein (CRP), a strong risk factor for metabolic and cardiovascular diseases, is a commonly used biomarker of meta-inflammation. As both PhA and CRP are influenced by age, BMI, and nutritional status, and exhibit a clear sex dimorphism, we examined the association between PhA and CRP levels in 1855 subjects (680 males and 1175 females), aged 18-59 years, with BMIs ranging from 19.5 to 69.4 kg/m, stratified according to sex. PhA values and CRP levels were significantly lower in females than males ( < 0.001), while the adherence to the Mediterranean diet (MD) was lower in males compared to females ( < 0.001). After adjusting for age, physical activity, BMI, waist circumference, and adherence to the MD, PhA remained negatively associated with CRP levels in both genders ( < 0.001). In the ROC analysis, PhA ≤ 5.5° in males and ≤5.4° in females were the threshold values predicting increased hs-CRP levels. These results suggested that PhA might represent a valid predictor of CRP levels in both sexes regardless of body weight and adherence to the MD, which avoids the collection of blood sampling and expensive biochemical assays.
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http://dx.doi.org/10.3390/nu13051446DOI Listing
April 2021

An Italian Survey on Dietary Habits and Changes during the COVID-19 Lockdown.

Nutrients 2021 Apr 5;13(4). Epub 2021 Apr 5.

Department of Pharmacy, University of Naples "Federico II", Via Domenico Montesano 49, 80131 Naples, Italy.

The World Health Organization has declared the coronavirus outbreak a Public Health Emergency of International Concern; the outbreak has led to lockdowns in several parts of the world, and sudden changes in people's lifestyles. This study explores the impact of the first coronavirus disease 2019 (COVID-19) pandemic period on dietary habits, lifestyle changes, and adherence to the Mediterranean diet among the Italian population, through an online questionnaire, conducted from April to May 2020, involving 1519 participants. The 14-point Mediterranean Diet Adherence Screener (MEDAS) highlighted a medium Mediterranean diet adherence in 73.5% of responders, which principally included the younger population, aged 18-30 years ( < 0.05). In regards to changes in eating habits, 33.5% of responders declared an influence of the pandemic period on nutritional practice. A decrease in alcohol consumption was reported by 81% of responders, while an increase in frozen food consumption was reported by 81.3% of responders. In addition, 58.8% reported positive weight modification (40.8%, +1-3 kg); physical activity reduction was reported for 70.5% of responders. Our study contributes toward amplifying the investigation on the dietary habits and changes of the Italian population during the COVID-19 lockdown, although the pandemic is ongoing. Similar studies should be performed around the world to understand how the emergency has impacted people's habits.
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http://dx.doi.org/10.3390/nu13041197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8065756PMC
April 2021

The clock diet: a practical nutritional guide to manage obesity through chrononutrition.

Minerva Med 2021 Apr 29. Epub 2021 Apr 29.

Endocrinology Unit, Department of Clinical Medicine and Surgery, Centro Italiano per la cura e il Benessere del paziente con Obesità (C.I.B.O), University Medical School of Naples, Naples, Italy.

Chronobiology studies the biological rhythms or circadian cycles of living organisms and their adaptation to external changes. Biological rhythms can affect hormone production cycles such as sleep/wake, and nutrition/fasting, but these factors can also alter the circadian rhythm (CR). In recent years, numerous studies have highlighted how feeding times and frequency can influence biological rhythms. Additionally, individuals' chronotype, working shifts, and food intake can make a deep impact on people's tendency to develop obesity and metabolic diseases. In this context, a single food and a specific combination of these, can also affect the CR and fasting cycle and consequently body weight and viceversa. The purpose of the review is to propose practical nutritional recommendations to help in resynchronizing the circadian rhythm as a tool in weight control.
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http://dx.doi.org/10.23736/S0026-4806.21.07207-4DOI Listing
April 2021

Phase angle and Mediterranean diet in patients with acne: Two easy tools for assessing the clinical severity of disease.

J Transl Med 2021 04 26;19(1):171. Epub 2021 Apr 26.

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Background: Acne is a chronic, inflammatory and debilitating skin disorder. Dietary factors and nutritional status are among the exacerbating factors of acne. Phase angle (PhA), a direct measure of Bioelectrical Impedance Analysis (BIA), represents an indicator of the chronic inflammatory state. The Mediterranean diet (MD) is a healthy dietary pattern that can exert anti-inflammatory effects in several inflammatory diseases. We aimed to investigate the difference in PhA and adherence to the MD and their associations with the severity of acne in a sample of naïve treatment patients with acne compared to control group.

Materials: In this cross-sectional, case-control, observational study, we enrolled 51 patients with acne and 51 control individuals. Body composition was evaluated by a BIA phase-sensitive system (50 kHz BIA 101 RJL, Akern Bioresearch, Florence, Italy, Akern). For adherence to the MD, we have used the PREvención con DIeta MEDiterránea (PREDIMED) questionnaire. The clinical severity of acne was assessed by using the global acne grading system (GAGS), a quantitative scoring system to assess acne severity.

Results: Patients with acne had a worse body composition, in particular smaller PhA (p = 0.003), and a lower adherence to the MD (p < 0.001) than the control group, in spite of no differences in gender, age and BMI between the two groups. Stratifying patients with acne according to GAGS categories, both PhA (p = 0.006) and PREDIMED score (p = 0.007) decreased significantly in severe acne than mild/moderate acne. The GAGS score was negative correlations with PhA (r = - 0.478, p < 0.001) and PREDIMED score (r = - 0.504, p < 0.001). The results of the multivariate analysis showed PhA and PREDIMED score were the major determinants of GAGS score (p < 0.001). The receiver operator characteristic (ROC) analysis reporting a value of PhA of ≤ 6.1° and a PREDIMED score of ≤ 9 identified patients with acne with the highest clinical severity of the disease.

Conclusions: Novel correlations were reported between PhA and the degree of adherence to the MD with acne severity. Of interest, PhA and PREDIMED scores might represent possible markers of the severity of acne in a clinical setting. This study highlights how a cooperation between dermatologist and nutritionists might provide a combination key in the complex management of acne patients.
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http://dx.doi.org/10.1186/s12967-021-02826-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8074493PMC
April 2021

European Guidelines for Obesity Management in Adults with a Very Low-Calorie Ketogenic Diet: A Systematic Review and Meta-Analysis.

Obes Facts 2021 21;14(2):222-245. Epub 2021 Apr 21.

Dipartimento di Medicina, Università degli Studi di Padova, Padova, Italy.

Background: The very low-calorie ketogenic diet (VLCKD) has been recently proposed as an appealing nutritional strategy for obesity management. The VLCKD is characterized by a low carbohydrate content (<50 g/day), 1-1.5 g of protein/kg of ideal body weight, 15-30 g of fat/day, and a daily intake of about 500-800 calories.

Objectives: The aim of the current document is to suggest a common protocol for VLCKD and to summarize the existing literature on its efficacy in weight management and weight-related comorbidities, as well as the possible side effects.

Methods: This document has been prepared in adherence with Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Literature searches, study selection, methodology development, and quality appraisal were performed independently by 2 authors and the data were collated by means of a meta-analysis and narrative synthesis.

Results: Of the 645 articles retrieved, 15 studies met the inclusion criteria and were reviewed, revealing 4 main findings. First, the VLCKD was shown to result in a significant weight loss in the short, intermediate, and long terms and improvement in body composition parameters as well as glycemic and lipid profiles. Second, when compared with other weight loss interventions of the same duration, the VLCKD showed a major effect on reduction of body weight, fat mass, waist circumference, total cholesterol and triglyceridemia as well as improved insulin resistance. Third, although the VLCKD also resulted in a significant reduction of glycemia, HbA1c, and LDL cholesterol, these changes were similar to those obtained with other weight loss interventions. Finally, the VLCKD can be considered a safe nutritional approach under a health professional's supervision since the most common side effects are usually clinically mild and easily to manage and recovery is often spontaneous.

Conclusions: The VLCKD can be recommended as an effective dietary treatment for individuals with obesity after considering potential contra-indications and keeping in mind that any dietary treatment has to be personalized. Prospero Registry: The assessment of the efficacy of VLCKD on body weight, body composition, glycemic and lipid parameters in overweight and obese subjects: a meta-analysis (CRD42020205189).
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http://dx.doi.org/10.1159/000515381DOI Listing
April 2021

Diet as a possible influencing factor in thyroid cancer incidence: the point of view of the nutritionist.

Panminerva Med 2021 04 20. Epub 2021 Apr 20.

Endocrinology Unit, Department of Clinical Medicine and Surgery, Centro Italiano per la Cura e il Benessere del Paziente con Obesità (C.I.B.O), University Medical School of Naples, Naples, Italy.

The incidence of differentiated thyroid cancer has increased in the last decades all over the world. Different environmental factors are possible perpetrators of this exponential growth. Nutritional factors are among the main environmental factors studied for thyroid cancer in recent years. This review aims to overview the main dietary factors involved in thyroid cancer risk, providing specific nutrition recommendations from the endocrinological Nutritionist point of view. Among the single food, fish and shellfish are the primary natural source of iodine, selenium and vitamin D in the human diet. These nutrients are essential for the synthesis of thyroid hormones; however, their consumption is not consistently related to thyroid cancer risk. The high intake of fruit and vegetables, probably due to their vitamin and antioxidant content, shows a weak inverse association with thyroid cancer risk. Alcohol, meat, or other food groups/nutrients showed no significant effect on thyroid cancer. In conclusion, to date, no definite association among dietary factors, specific dietary patterns, and thyroid cancer, and its clinical severity and aggressiveness have been found. However, it is essential to underline that in the future, prospective studies should be carried out to precisely evaluate the qualitative and quantitative intake of nutrients by patients to establish with more confidence a potential correlation between food intake and the occurrence and development of thyroid cancer.
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http://dx.doi.org/10.23736/S0031-0808.21.04213-0DOI Listing
April 2021

Cut-off for the Mediterranean diet score to identify subjects with morning chronotype in middle-aged Italian adults.

Minerva Endocrinol (Torino) 2021 Apr 15. Epub 2021 Apr 15.

Unit of Endocrinology, Dipartimento di Medicina Clinica e Chirurgia, Federico II University Medical School of Naples, Naples, Italy.

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http://dx.doi.org/10.23736/S2724-6507.21.03411-8DOI Listing
April 2021

What about Mediterranean diet as tool to improve sleep quality in obesity?

Minerva Endocrinol (Torino) 2021 Apr 15. Epub 2021 Apr 15.

Unit of Endocrinology, Dipartimento di Medicina Clinica e Chirurgia, Federico II University Medical School of Naples, Naples, Italy.

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http://dx.doi.org/10.23736/S2724-6507.21.03410-6DOI Listing
April 2021

Cardio-Metabolic Indices and Metabolic Syndrome as Predictors of Clinical Severity of Gastroenteropancreatic Neuroendocrine Tumors.

Front Endocrinol (Lausanne) 2021 18;12:649496. Epub 2021 Mar 18.

Centro Italiano per la cura e il Benessere del paziente con Obesità (C.I.B.O), Endocrinology Unit, Department of Clinical Medicine and Surgery, University Medical School of Naples, Naples, Italy.

Background: Obesity, mainly visceral obesity, and metabolic syndrome (MetS) are major risk factors for the development of type 2 diabetes, cardiovascular diseases, and cancer. Data analyzing the association of obesity and MetS with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) are lacking. Fatty liver index (FLI) is a non-invasive tool for identifying individuals with non-alcoholic fatty liver disease (NAFLD). Visceral adiposity index (VAI) has been suggested as a gender-specific indicator of adipose dysfunction. Both indexes have been proposed as early predictors of MetS. This study aimed to investigate the association of FLI VAI as early predictors of MetS with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Methods: A cross-sectional, case-control, observational study was carried out at the ENETS Centers of Excellence Multidisciplinary Group for Neuroendocrine Tumors, University "Federico II". VAI and FLI were calculated.

Results: We enrolled 109 patients with histologically confirmed G1/G2 GEP-NET (53 M; 57.06 ± 15.96 years), as well as 109 healthy subjects, age, sex- and body mass index-matched. Forty-four GEP-NET patients were G2, of which 21 were with progressive disease, and 27 patients had metastases. GEP-NET patients had a higher value of VAI ( < 0.001) and FLI ( = 0.049) and higher MetS presence ( < 0.001) compared with controls. VAI and FLI values and MetS presence were higher in G2 than in G1 patients ( < 0.001), in patients with progressive disease, and in metastatic non-metastatic patients ( < 0.001). In addition, higher values of VAI and FLI and higher MetS presence were significantly correlated with the worst clinical severity of NENs. The cut-off values for the FLI and MetS to predict high grading of GEP-NETs and the presence of metastasis were also provided.

Conclusions: This is the first study investigating an association between VAI and FLI as early predictors of MetS and GEP-NET. Our findings report that the worsening of clinicopathological characteristics in GEP-NET is associated with higher presence of MetS, NAFLD, evaluated by FLI, and visceral adiposity dysfunction, evaluated by VAI. Addressing the clinical evaluation of MetS presence, NAFLD, and visceral adiposity dysfunction might be of crucial relevance to establish targeted preventive and treatment interventions of NEN-related metabolic comorbidities.
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http://dx.doi.org/10.3389/fendo.2021.649496DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018238PMC
March 2021

Nutritional guidelines for the management of insulin resistance.

Crit Rev Food Sci Nutr 2021 Apr 2:1-14. Epub 2021 Apr 2.

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università "Federico II" di Napoli, Via Sergio Pansini, 5, Naples, Italy.

Obesity and its related co-morbidities, namely type 2 diabetes (T2D), pose a significant global public health problem. Insulin resistance (IR) in muscle and liver is the core pathophysiologic defect that underlies obesity preceding and predicting the onset of T2D in susceptible humans. There is a broad population with IR that has no indication for prescription of medications, who still need medical consultation and specific advice in this respect. This prevalent need can be achieved by appropriate diet, exercise, and other behavioral therapies for lifestyle interventions. Despite a well-recognized role of IR in the progression to metabolic diseases, no specific nutritional recommendations exist to manage this condition, to the best of our knowledge. An international panel of experts reviewed and critically appraised the updated literature published about this topic. This review primarily examines the evidence for areas of consensus and ongoing uncertainty or controversy about diet and exercise approaches for IR. The aim of this article is to present the most common IR states, namely obesity and Polycystic Ovary Syndrome (PCOS), and provide nutritional advice to manage IR, hyperinsulinemia, and reactive hypoglycemia. These nutritional guidelines could prevent progression or worsening of IR with resultant beta-cell failure and, as a result, T2D.
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http://dx.doi.org/10.1080/10408398.2021.1908223DOI Listing
April 2021

Chronotype and cardio metabolic health in obesity: does nutrition matter?

Int J Food Sci Nutr 2021 Mar 24:1-9. Epub 2021 Mar 24.

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università "Federico II" di Napoli, Naples, Italy.

The aim of the study was to investigate the association of chronotype categories with type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) in 172 middle-aged adults (71.5% females; 51.8 ± 15.7 years). Anthropometric parameters, lifestyle habits, adherence to the Mediterranean Diet (MD), sleep quality, chronotype and the presence of T2DM and CVD were studied. Chronotype was classified as morning in 58.1% of subjects, evening in 12.8% and intermediate in 28.1%. Subjects with evening chronotype followed an unhealthier lifestyle than other chronotypes; indeed, they significantly performed less regular activity and were more frequently smokers. Furthermore, they had significantly higher risk to have T2DM [Odds Ratio (OR)=3.36 95% confidence interval (CI) 1.14-35.42;  = 0.03] and CVD [Odds Ratio (OR)= 5.89 95% CI 1.14-30.60;  = 0.035](CI) 2.24-407.54);  = 0.01] compared to morning chronotype after adjustment for gender, body mass index (BMI), sleep quality and adherence to the MD. The confidence intervals were wide, indicating that the sample size was too small. Thus, these data need to be replicated in a larger sample size. In addition, nutritional assessment was limited since only PREDIMED questionnaire was carried out. However, the main strengths of this study included a random sample and a population-based approach, although the cross-sectional design cannot establish causality. Although study population was unbalanced per gender and smoking and age group representing only middle-aged people,we adjusted the statistical analysis for potential confounding factors. In conclusion, the evening chronotype has an increased risk to be associated to T2DM and CVD.
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http://dx.doi.org/10.1080/09637486.2021.1885017DOI Listing
March 2021

The impact of obesity on immune response to infection: Plausible mechanisms and outcomes.

Obes Rev 2021 Mar 14:e13216. Epub 2021 Mar 14.

Dipartimento di Medicina Clinica e Chirurgia, Unità di Endocrinologia, Università Federico II di Napoli, Napoli, Italy.

Emerging data suggest an association between obesity and infectious diseases. Although the mechanisms underlying this link are not well established, a number of potential factors may be involved. Indeed, the obesity-related vulnerability to infectious diseases could be due to chronic low-grade inflammation, hyperglycemia, hyperinsulinemia, and hyperleptinemia, which lead to a weakening of both the innate and adaptive immune responses. In addition, obesity results in anatomical-functional changes by the mechanical obstacle of excessive adipose tissue that blunt the respiratory mechanisms and predisposing to respiratory infections. Subjects with obesity are also at risk of skin folds and sweat more profusely due to the thick layers of subcutaneous fat, favoring the proliferation of microorganisms and slowing the repair of wounds down. All these factors make subjects with obesity more prone to develop nosocomial infections, surgical site, skin and soft tissue infections, bacteremia, urinary tract infections, and mycosis. Furthermore, infections in subjects with obesity have a worse prognosis, frequently prolonging hospitalization time as demonstrated for several flu viruses and recently for COVID-19. Thus, the aim of this manuscript is to provide an overview of the current clinical evidence on the associations between obesity and infectious diseases highlighting physio pathological insights involved in this link.
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http://dx.doi.org/10.1111/obr.13216DOI Listing
March 2021

Impact of Long-Term Growth Hormone Replacement Therapy on Metabolic and Cardiovascular Parameters in Adult Growth Hormone Deficiency: Comparison Between Adult and Elderly Patients.

Front Endocrinol (Lausanne) 2021 25;12:635983. Epub 2021 Feb 25.

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università degli Studi di Napoli Federico II, Naples, Italy.

Growth hormone deficiency (GHD) in adults is due to a reduced growth hormone (GH) secretion by the anterior pituitary gland which leads to a well-known syndrome characterized by decreased cognitive function and quality of life (QoL), decreased bone mineral density (BMD), increased central adiposity with a reduction in lean body mass, decreased exercise tolerance, hyperlipidemia and increased predisposition to atherogenesis. Considering some similar features between aging and GHD, it was thought that the relative GH insufficiency of the elderly person could make an important contribution to the fragility of elderly. GH stimulation tests are able to differentiate GHD in elderly patients (EGHD) from the physiological reduction of GH secretion that occurs with aging. Although there is no evidence that rhGH replacement therapy increases the risk of developing Diabetes Mellitus (DM), reducing insulin sensitivity and inducing cardiac hypertrophy, long-term monitoring is, however, also mandatory in terms of glucose metabolism and cardiovascular measurements. In our experience comparing the impact of seven years of rhGH treatment on metabolic and cardiovascular parameters in GHD patients divided in two groups [adult (AGHD) and elderly (EGHD) GHD patients], effects on body composition are evident especially in AGHD, but not in EGHD patients. The improvements in lipid profile were sustained in all groups of patients, and they had a lower prevalence of dyslipidemia than the general population. The effects on glucose metabolism were conflicting, but approximately unchanged. The risk of DM type 2 is, however, probably increased in obese GHD adults with impaired glucose homeostasis at baseline, but the prevalence of DM in GHD is like that of the general population. The increases in glucose levels, BMI, and SBP in GHD negatively affected the prevalence of Metabolic Syndrome (MS) in the long term, especially in AGHD patients. Our results are in accordance to other long-term studies in which the effects on body composition and lipid profile are prominent.
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http://dx.doi.org/10.3389/fendo.2021.635983DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7947790PMC
February 2021

Multiple hormonal and metabolic deficiency syndrome predicts outcome in heart failure: the T.O.S.CA. Registry.

Eur J Prev Cardiol 2021 Mar 7. Epub 2021 Mar 7.

Clinical Medicine and Surgery Department, Federico II University, Naples, Italy.

Aims: Recent evidence supports the occurrence of multiple hormonal and metabolic deficiency syndrome (MHDS) in chronic heart failure (CHF). However, no large observational study has unequivocally demonstrated its impact on CHF progression and outcome. The T.O.S.CA. (Trattamento Ormonale nello Scompenso CArdiaco; Hormone Treatment in Heart Failure) Registry has been specifically designed to test the hypothesis that MHDS affects morbidity and mortality in CHF patients.

Methods And Results: The T.O.S.CA. Registry is a prospective, multicentre, observational study involving 19 Italian centres. Thyroid hormones, insulin-like growth factor-1, total testosterone, dehydropianoandrosterone sulfate, insulin resistance, and the presence of diabetes were evaluated. A MHDS was defined as the presence of ≥2 hormone deficiencies (HDs). Primary endpoint was a composite of all-cause mortality and cardiovascular hospitalizations. Four hundred and eighty heart failure patients with ejection fraction ≤45% were enrolled. MHDS or diabetes was diagnosed in 372 patients (77.5%). A total of 271 events (97 deaths and 174 cardiovascular hospitalizations) were recorded, 41% in NO-MHDS and 62% in MHDS (P < 0.001). Median follow-up was of 36 months. MHDS was independently associated with the occurrence of the primary endpoint [hazard ratio 95% (confidence interval), 1.93 (1.37-2.73), P < 0.001] and identified a group of patients with a higher mortality [2.2 (1.28-3.83), P = 0.01], with a graded relation between HDs and cumulative events (P < 0.01).

Conclusion: MHDS is common in CHF and independently associated with increased all-cause mortality and cardiovascular hospitalization, representing a promising therapeutic target.

Trial Registration: ClinicalTrials.gov identifier: NCT023358017.
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http://dx.doi.org/10.1093/eurjpc/zwab020DOI Listing
March 2021

Primary Neuroendocrine Neoplasms of the Breast: Still Open Issues.

Front Endocrinol (Lausanne) 2020 26;11:610230. Epub 2021 Jan 26.

Endocrinology Unit, Department of Clinical Medicine and Surgery, University "Federico II", Naples, Italy.

Neuroendocrine breast tumors represent a rare subtype of breast cancer, accounting for less than 1% of all neuroendocrine neoplasms. Starting from their pathology definition, and going through their prevalence, prognosis and treatment, our knowledge is still really uncertain. In the present short review of the medical literature on this topic, we have evaluated in details their epidemiology, risk factors, pathogenesis, pathology, clinical presentation, radiographic aspects, prognosis, and therapy. We have thus been able to identify a number of open issues regarding primary neuroendocrine neoplasms of the breast that need to be clarified. Our ultimate aim was actually to try to understand whether neuroendocrine neoplasms of the breast can be considered a definite clinical entity and if neuroendocrine differentiation of breast tumors has a really clinical relevance.
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http://dx.doi.org/10.3389/fendo.2020.610230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7874233PMC
January 2021

An Innovative Approach to Designing Digital Health Solutions Addressing the Unmet Needs of Obese Patients in Europe.

Int J Environ Res Public Health 2021 01 12;18(2). Epub 2021 Jan 12.

Dipartimento di Sanità Pubblica, Università degli studi di Napoli Federico II, via S. Pansini n.5, 80131 Naples, Italy.

According to the World Health Organization (WHO), the worldwide obesity rate has tripled since 1975. In Europe, more than half of the population is overweight and obese. Around 2.8 million people die each year worldwide as a result of conditions linked to being overweight or obese. This study aimed to analyze the policies, approaches, and solutions that address the social and health unmet needs of obese patients, at different levels, in order to simulate the definition of an integrated approach, and to provide and share examples of innovative solutions supporting health promotion, disease prevention, and integration of services to improve the collaboration between the different health and care stakeholders involved across the country and in the lives of obese patients. A collaborative approach involving various levels of government and regional experts from different European countries was applied to identify, explore, and evaluate different aspects of the topic, from the innovation perspective and focusing on a European and a regional vision. Currently, people prefer more foods rich in fats, sugars, and salt/sodium than fruits, vegetables, and fiber. This behavior leads to a significant negative impact on their health-related quality of life. Changes in healthcare systems, healthy policy, and approaches to patient care and better implementation of the different prevention strategies between all the stakeholders are needed, taking advantage of the digital transformation of health and care. Such changes can support obese patients in their fight against an unhealthy lifestyle and at the same time reduce healthcare costs.
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http://dx.doi.org/10.3390/ijerph18020579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826628PMC
January 2021

Risk factors and management of pasireotide-associated hyperglycemia in acromegaly.

Endocr Connect 2020 Dec;9(12):1178-1190

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, Naples, Italy.

Pasireotide, a multireceptor-targeted somatostatin analog with highest affinity for somatostatin receptor subtype (SST) 5, has demonstrated superior efficacy over the SST2-preferential somatostatin analogs octreotide and lanreotide. The safety profile is similar to those of octreotide and lanreotide, except for a higher frequency and degree of hyperglycemia. This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA). One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies. Of patients treated with pasireotide in studies C2305 and C2402, respectively, 75.3 (134/178) and 65.6% (82/125) developed hyperglycemia or experienced worsening of existing hyperglycemia. Occurrence of hyperglycemia during pasireotide treatment was less frequent in patients with lower age (<40 years, C2402; <30 years, C2305), normal glucose tolerance, and no history of hypertension or dyslipidemia at baseline. Thirteen (4%) patients discontinued pasireotide because of hyperglycemia-related adverse events. Metformin alone or in combination with other oral antidiabetic medications controlled elevations in glucose levels in most pasireotide-treated patients; 78% of C2305 patients and 73 (pasireotide 40 mg) and 60% (pasireotide 60 mg) of C2402 patients achieved the ADA/EASD goal of HbA1c <7% (<53 mmol/mol) at the end of the core phase. Not all patients develop hyperglycemia, and it is reversible upon pasireotide withdrawal. Close monitoring, patient education and prompt action remain key elements in addressing hyperglycemia during pasireotide treatment.
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http://dx.doi.org/10.1530/EC-20-0361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7774766PMC
December 2020

Clinical Epigenetics of Neuroendocrine Tumors: The Road Ahead.

Front Endocrinol (Lausanne) 2020 15;11:604341. Epub 2020 Dec 15.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Neuroendocrine tumors, or NETs, are cancer originating in neuroendocrine cells. They are mostly found in the gastrointestinal tract or lungs. Functional NETs are characterized by signs and symptoms caused by the oversecretion of hormones and other substances, but most NETs are non-functioning and diagnosis in advanced stages is common. Thus, novel diagnostic and therapeutic strategies are warranted. Epigenetics may contribute to refining the diagnosis, as well as to identify targeted therapy interfering with epigenetic-sensitive pathways. The goal of this review was to discuss the recent advancement in the epigenetic characterization of NETs highlighting their role in clinical findings.
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http://dx.doi.org/10.3389/fendo.2020.604341DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7770585PMC
December 2020

Emerging Therapies in Pheochromocytoma and Paraganglioma: Immune Checkpoint Inhibitors in the Starting Blocks.

J Clin Med 2020 Dec 29;10(1). Epub 2020 Dec 29.

Department of Clinical and Molecular Medicine, Sapienza University of Rome, 00161 Rome, Italy.

Pheochromocytoma and paraganglioma are neuroendocrine neoplasms, originating in the adrenal medulla and in parasympathetic and sympathetic autonomic nervous system ganglia, respectively. They usually present as localized tumours curable with surgery. However, these tumours may exhibit heterogeneous clinical course, ranging from no/minimal progression to aggressive (progressive/metastatic) behavior. For this setting of patients, current therapies are unsatisfactory. Immune checkpoint inhibitors have shown outstanding results for several types of solid cancers. We therefore aimed to summarize and discuss available data on efficacy and safety of current FDA-approved immune checkpoint inhibitors in patients with pheochromocytoma and paraganglioma. After an extensive search, we found 15 useful data sources (four full-published articles, four supplements of scientific journals, seven ongoing registered clinical trials). The data we detected, even with the limit of the small number of patients treated, make a great expectation on the therapeutic use of immune checkpoint inhibitors. Besides, the newly detected predictors of response will (hopefully) be of great helps in selecting the subset of patients that might benefit the most from this class of drugs. Finally, new trials are in the starting blocks, and they are expected to shed in the next future new light on a therapy, which is considered a milestone in oncology.
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http://dx.doi.org/10.3390/jcm10010088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795591PMC
December 2020

Medical Treatment of Cushing's Disease: An Overview of the Current and Recent Clinical Trials.

Front Endocrinol (Lausanne) 2020 8;11:648. Epub 2020 Dec 8.

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, Naples, Italy.

Cushing's disease (CD) is a serious endocrine disorder characterized by chronic hypercortisolism, or Cushing's syndrome (CS), caused by a corticotroph pituitary tumor, which induces an excessive adrenocorticotropic hormone (ACTH) and consequently cortisol secretion. CD presents a severe clinical burden, with impairment of the quality of life and increase in mortality. Pituitary surgery represents the first-line therapy, but it is non-curative in one third of patients, requiring additional treatments. Among second-line treatments, medical therapy is gradually gaining importance, although the current medical treatments are unable to reach optimal efficacy and safety profile. Therefore, new drugs and new formulations of presently available drugs are currently under clinical investigation in international clinical trials, in order to assess their efficacy and safety in CD, or in the general population of CS. Among pituitary-directed agents, pasireotide, in the twice-daily subcutaneous formulation, has been demonstrated to be an effective treatment both in clinical trials and in real-world studies, and extension studies of the phase II and III clinical trials reported evidence of long-term efficacy with general good safety profile, although associated with frequent hyperglycemia, which requires monitoring of glucose metabolism. Moreover, the most recent once-monthly intramuscular formulation, pasireotide long-acting release (LAR), showed similar efficacy and safety, but associated with potential better compliance profile in CD. Roscovitine is an experimental drug currently under investigation. Among adrenal-directed agents, metyrapone is the only historical agent currently under investigation in a prospective, multicenter, international clinical trial, that would likely clarify its efficacy and safety in a large population of patients with CS. Osilodrostat, a novel agent with a mechanism of action similar to metyrapone, seems to offer a rapid, sustained, and effective disease control of CD, according to recently completed clinical trials, whereas levoketoconazole, a different chemical formulation of the historical agent ketoconazole, is still under investigation in clinical trials, with preliminary evidences showing an effective and safe control of CS. ATR-101 is an experimental drug currently under investigation. Among glucocorticoid receptor-directed drugs, mifepristone has been demonstrated to improve clinical syndrome and comorbidities, especially hypertension and impairment of glucose metabolism, but the occurrence of hypokalemia and in women uterine disorders, due to the concomitant action on progestin receptor, requires caution, whereas the preliminary evidence on relacorilant, characterized by high selectivity for glucocorticoid receptor, suggested good efficacy in the control of hypertension and impairment of glucose metabolism, as well as a good safety profile, in CS. Finally, a limited experience has demonstrated that combination therapy might be an interesting approach in the management of CD. The current review provides a summary of the available evidences from current and recent clinical trials on CD, with a specific focus on preliminary data.
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http://dx.doi.org/10.3389/fendo.2020.00648DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753248PMC
December 2020

School as ideal setting to promote health and wellbeing among young people.

Health Promot Perspect 2020 7;10(4):316-324. Epub 2020 Nov 7.

Department of Environmental Science and Policy, University of Milan, Milan, Italy.

Nowadays, young people face several health challenges. As children and teenagers spend most of their time in the classroom, schools may have the opportunity to positively influence students' quality of life, playing a crucial role in fostering their health. The aim of this review was to analyze evidence that demonstrated why school is the ideal setting for thepromotion of young generations' wellbeing. We have reviewed the available literature about health promotion in school setting, searching for articles and books published from 1977 to 2020. A total of 74 articles and 17books were selected and assessed. The promotion of students' wellbeing could reduce the prevalence of measurable unhealthy outcomes and improve their academic achievements. At least 80% of all cases of heart diseases, strokes, type 2 diabetes and one third of all cancers can be prevented through health education. In this perspective, primary prevention and health promotion should start as early as possible, finding in the school the ideal setting of action. Effective school-based preventive approaches should raise students' motivation towards a personal interiorization of health knowledge and develop in young people a critical thinking about harmful consequences of the most common risky behaviours. Educators should receive adequate training concerning health topics and become expert in the most innovative approaches to effectively engage students in adopting healthy lifestyles. As primary educational institution, school should integrate students' health promotion in its ordinary teaching and learning practices in the perspective of "better health through better schools".
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http://dx.doi.org/10.34172/hpp.2020.50DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723000PMC
November 2020

Could ketogenic diet "starve" cancer? Emerging evidence.

Crit Rev Food Sci Nutr 2020 Dec 4:1-22. Epub 2020 Dec 4.

Dipartimento di Medicina Clinica e Chirurgia, Unit of Endocrinology, Federico II University Medical School of Naples, Naples, Italy.

Cancer cells (CCs) predominantly use aerobic glycolysis (Warburg effect) for their metabolism. This important characteristic of CCs represents a potential metabolic pathway to be targeted in the context of tumor treatment. Being this mechanism related to nutrient oxidation, dietary manipulation has been hypothesized as an important strategy during tumor treatment. Ketogenic diet (KD) is a dietary pattern characterized by high fat intake, moderate-to-low protein consumption, and very-low-carbohydrate intake (<50 g), which in cancer setting may target CCs metabolism, potentially influencing both tumor treatment and prognosis. Several mechanisms, far beyond the originally proposed inhibition of glucose/insulin signaling, can underpin the effectiveness of KD in cancer management, ranging from oxidative stress, mitochondrial metabolism, and inflammation. The role of a qualified Nutritionist is essential to reduce and manage the short and long-term complications of this dietary therapy, which must be personalized to the individual patient for the planning of tailored KD protocol in cancer patients. In the present review, we summarize the proposed antitumor mechanisms of KD, the application of KD in cancer patients with obesity and cachexia, and the preclinical and clinical evidence on KD therapy in cancer.
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http://dx.doi.org/10.1080/10408398.2020.1847030DOI Listing
December 2020

A practical nutritional guide for the management of sleep disturbances in menopause.

Int J Food Sci Nutr 2020 Nov 30:1-15. Epub 2020 Nov 30.

Dipartimento di Medicina Clinica e Chirurgia, Unit of Endocrinology, Federico II University Medical School of Naples, Naples, Italy.

Sleep disturbances (SD) represent one of the main symptoms of menopause and they are caused by several factors. Hormonal changes such as the reduction of oestrogen levels and the consequent vasomotor symptoms (VMS) along with psychiatric disorders such as depression and anxiety could contribute to the onset of SD. Furthermore, obesity or through the obstructive sleep apnoea (OSA) could blunt sleep. Moreover, in menopause is usual a reduction in melatonin, that could contribute to SD. Nutritional strategies are paramount because they could contribute to manage menopause-related SD, in particular tackling obesity and overweight. Furthermore, some foods, such as soy, fish, whole grains, vegetables and fruit could decrease symptoms like depression and VMS, correlated with SD in postmenopausal women. Therefore, the aim of this review is to provide an overview of the current evidence on SD in menopause and to provide nutritional strategies for managing SD in this context.
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http://dx.doi.org/10.1080/09637486.2020.1851658DOI Listing
November 2020

SEX DISPARITIES IN COVID-19 SEVERITY AND OUTCOME: ARE MEN WEAKER OR WOMEN STRONGER?

Neuroendocrinology 2020 Nov 26. Epub 2020 Nov 26.

The COVID-19 outbreak is a global public health issue, having profound effects on most aspects of societal well-being, including physical and mental health. A plethora of studies, globally, have suggested the existence of a sex disparity in the outcome of COVID-19 patients, that is mainly due to mechanisms of viral infection, immune response to the virus, development of a hyperinflammation, and development of systemic complications, particularly thromboembolism. These differences appear to be more pronounced in elderly COVID-19 patients. Epidemiological data report a sex difference in the severity and outcome of COVID-19 disease with a more favourable course of the disease in women compared to men, regardless of age range although the rate of SARS-CoV-2 infection seems to be similar in both sexes. Sex hormones, including androgens and estrogens, may not only impact viral entry and load, but also shape the clinical manifestations, complications and, ultimately, the outcome of COVID-19 disease. The current review comprehensively summarizes current literature on sex disparities in susceptibility and outcomes of COVID-19 disease as well as the literature underpinning the pathophysiological and molecular mechanisms, which may provide a rationale to a sex disparity. These include sex hormone influences on molecules that facilitate virus entry and priming, as well as the immune and inflammatory response, as well as coagulation and thrombosis diathesis. Based on present evidence, women appear to be relatively protected from COVID-19 because of a more effective immune response and a less pronounced systemic inflammation, with consequent moderate clinical manifestations of the disease, together with a lesser predisposition to thromboembolism. Conversely, men appear to be particularly susceptible to COVID-19 disease because of a less effective immune response with consequent increased susceptibility to infections, together with a greater predisposition to thromboembolism. In elderlies, sex disparities in overall mortality following SARS-CoV-2 infection is even more palpable, as elderly men appear more prone to severe COVID-19 because of a greater predisposition to infections, a weaker immune defence and an enhanced thrombotic state compared to women. The review highlights potential novel therapeutic approaches employing the administration of hormonal or anti-hormonal therapy in combination with antiviral drugs in COVID-19 patients.
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http://dx.doi.org/10.1159/000513346DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900484PMC
November 2020

Improving sleep disturbances in obesity by nutritional strategies: review of current evidence and practical guide.

Int J Food Sci Nutr 2020 Nov 25:1-13. Epub 2020 Nov 25.

Department of Clinical Medicine and Surgery, Endocrinology Unit, University Federico II, Naples, Italy.

Over the past decades, there has been an increase in overweight and obesity worldwide rates in both in adult and children. In parallel, it has been reported a worsening of sleep duration and quality. Some studies have shown an association between obesity and sleep disturbances (SD) subjects with obesity have a greater risk of SD. As well as SD influences diet, also food choices have been shown to influence various sleep-related variables, such as duration and quality. For this reason, nutrition could represent an important tool not only to lose weight but also to improve sleep in patients with obesity and sleep disturbances. Thus, the aim of this review is to provide an overview of the studies that assessed the association between obesity and SD and , highlighting possible nutritional advices as a tool to improve sleep in patients with obesity and sleep disturbances.
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http://dx.doi.org/10.1080/09637486.2020.1851659DOI Listing
November 2020

Vitamin D in obesity and obesity-related diseases: an overview.

Minerva Endocrinol 2020 Nov 19. Epub 2020 Nov 19.

Dipartimento di Medicina Clinica e Chirurgia, Unit of Endocrinology, Collaborating Centres for Obesity Management (COM) of The European Association for the Study of Obesity (EASO).

Hypovitaminosis D and obesity represent two pandemic conditions sometimes associated with each other. Although it is known that there is a close relationship between these two health problems, the underlying pathophysiological mechanism has not yet been fully clarified. In fact, on the one hand, obesity per se seems to involve low circulating levels of vitamin D due to low sun exposure, physical activity, and intake of foods rich in vitamin D, volumetric dilution and sequestration in the adipose tissue. Conversely, since pre-adipocytes and adipocytes express the receptors and are involved in the metabolism of vitamin D it would seem that low levels of this vitamin may be involved in adipogenesis and therefore in the development of obesity. This connection is extremely important when considering obesity-related diseases. In fact, low vitamin D levels and severe obesity are significantly associated with some cardio-metabolic risk factors, including high body mass index, waist circumference, blood pressure, impaired lipid and glycemic profile, and insulin resistance, as they would seem associated with worse cardiovascular outcomes and higher cancer incidence and mortality. Therefore, the purpose of this review is to examine the recent evidence linking low vitamin D status, obesity and obesity-related diseases, highlighting the scientific achievements and the gaps to be filled with further investigations.
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http://dx.doi.org/10.23736/S0391-1977.20.03299-XDOI Listing
November 2020