Publications by authors named "María Molina-Vega"

23 Publications

  • Page 1 of 1

Factors Related to Weight Loss Maintenance in the Medium-Long Term after Bariatric Surgery: A Review.

J Clin Med 2021 Apr 16;10(8). Epub 2021 Apr 16.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Málaga, Spain.

Despite bariatric surgery being the most effective treatment for obesity, some individuals do not respond adequately, especially in the long term. Identifying the predictors of correct weight maintenance in the medium (from 1 to 3 years after surgery) and long term (from 3 years and above) is of vital importance to reduce failure after bariatric surgery; therefore, we summarize the evidence about certain factors, among which we highlight surgical technique, psychological factors, physical activity, adherence to diet, gastrointestinal hormones or neurological factors related to appetite control. We conducted a search in PubMed focused on the last five years (2015-2021). Main findings are as follows: despite Roux-en-Y gastric bypass being more effective in the long term, sleeve gastrectomy shows a more beneficial effectiveness-complications balance; pre-surgical psychological and behavioral evaluation along with post-surgical treatment improve long-term surgical outcomes; physical activity programs after bariatric surgery, in addition to continuous and comprehensive care interventions regarding diet habits, improve weight loss maintenance, but it is necessary to improve adherence; the impact of bariatric surgery on the gut-brain axis seems to influence weight maintenance. In conclusion, although interesting findings exist, the evidence is contradictory in some places, and long-term clinical trials are necessary to draw more robust conclusions.
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http://dx.doi.org/10.3390/jcm10081739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8073104PMC
April 2021

MeDiGes Study. Metformin versus insulin in gestational diabetes: Glycemic control, and obstetrical and perinatal outcomes. Randomized prospective trial.

Am J Obstet Gynecol 2021 Apr 19. Epub 2021 Apr 19.

Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga. IBIMA; CIBER de Diabetes y Enfermedades Metabólicas (CIBERDEM).

Background: Gestational diabetes not properly controlled with diet has been commonly treated with insulin. In recent years several studies have published that metformin can lead to, at least, similar obstetrical and perinatal outcomes as insulin. Nevertheless, not all clinical guidelines endorse its use, and clinical practice is heterogeneous.

Objectives: The aim of this study was to test if metformin could achieve the same glycemic control as insulin and similar obstetrical and perinatal results, with a good safety profile, in women with gestational diabetes not properly controlled with lifestyle changes.

Study Design: The MeDiGes study was a multicenter, open-label, parallel arms, randomized clinical trial performed at two hospitals in Málaga (Spain), enrolling women with GDM who needed pharmacological treatment. Women aged 18-45 years, in the second or third trimesters of pregnancy, were randomized to receive metformin or insulin (Detemir and/or Aspart). The main outcomes were: 1. glycemic control (mean glycemia, pre-prandial and postprandial) and hypoglycemic episodes, and 2. obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice). Outcomes were analyzed on an intention-to-treat basis.

Results: Between 2016-October and 2019-June 200 women were randomized, 100 to the insulin-treated group and 100 to the metformin-treated group. Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch and/or dinner in the metformin-treated-group. Hypoglycemic episodes were significantly more common in the insulin-treated group (55.9% vs 17.7% on metformin, OR 6.118, 95% CI 3.134-11.944, p 0.000). Women treated with metformin gained less weight from the enrollment to the prepartum visit (36-37 gestational weeks) (1.35±3.21 vs 3.87±3.50 Kg, p 0.000). Labor inductions (MET 45.7% vs INS 62.5%, OR 0.506, 95% CI 0.283-0.903, p 0.029) and cesarean deliveries (MET 27.6% vs INS 52.6%, OR 0.345, 95% CI 0.187-0.625, p 0.001) were significantly lower in the MET-group. Mean birth weight, macrosomia and large for gestational age were not different between treatment groups, as well as babies' complications. The lower cesarean delivery rate for women treated with metformin was not associated with macrosomia, large or small for gestational age, or other complications of pregnancy.

Conclusions: Metformin treatment was associated with a better postprandial glycemic control than insulin for some meals, a lower risk of hypoglycemic episodes, less maternal weight gain, and a low rate of failure as an isolated treatment. Most obstetrical and perinatal outcomes were similar between groups.
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http://dx.doi.org/10.1016/j.ajog.2021.04.229DOI Listing
April 2021

Different Weight Loss Intervention Approaches Reveal a Lack of a Common Pattern of Gut Microbiota Changes.

J Pers Med 2021 Feb 8;11(2). Epub 2021 Feb 8.

Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), 29010 Málaga, Spain.

Options for treatment of obesity include dietary approaches and bariatric surgery. Previous studies have shown that weight loss interventions have an impact on gut microbiota. However, a pattern of gut microbiota changes associated with weight loss independently of the type of intervention has not been described yet. This study includes 61 individuals who followed different weight loss strategies in three different trials: 21 followed a hypocaloric Mediterranean diet (MedDiet), 18 followed a very-low-calorie ketogenic diet (VLCKD) and 22 patients underwent sleeve gastrectomy bariatric surgery (BS). Gut microbiota profile was assessed by next-generation sequencing. A common taxon that had significantly changed within the three weight loss interventions could not be find. At the family level, significantly increased its abundance with MedDiet and VLCKD, whilst and significantly increased with VLCKD and BS. At genus level, in VLCKD and BS, and significantly increased their abundance whilst decreased. At the species level, BS and VLCKD produced an increase in and a decrease in and , whilst increased its abundance after the BS and MedDiet. Predicted metagenome analysis suggested that most of the changes after VLCKD were focused on pathways related to biosynthesis and degradation/utilization/assimilation, while BS seems to decrease most of the biosynthesis pathways. MedDiet was enriched in several pathways related to fermentation to short-chain fatty acids. Our results show that weight loss is not associated with a specific pattern of gut microbiota changes independently of the strategy used. Indeed, gut microbiota changes according to type of weight loss intervention.
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http://dx.doi.org/10.3390/jpm11020109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7915884PMC
February 2021

Measurement of Serum Testosterone in Nondiabetic Young Obese Men: Comparison of Direct Immunoassay to Liquid Chromatography-Tandem Mass Spectrometry.

Biomolecules 2020 12 19;10(12). Epub 2020 Dec 19.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Malaga, Spain.

Hypoandrogenemia, a frequent finding in men with obesity, is defined by low concentrations of serum testosterone. Although immunoassay (IA) is the most used method for the determination of this steroid in clinical practice, liquid chromatography-mass spectrometry (LC-MS/MS) is considered a more reliable method. In this study, we aimed to compare IA versus LC-MS/MS measurement for the diagnosis of hypoandrogenemia in a cohort of 273 nondiabetic young obese men. Mean total testosterone (TT) levels were 3.20 ± 1.24 ng/mL for IA and 3.78 ± 1.4 ng/mL for LC-MS/MS. 53.7% and 26.3% of patients were classified as presenting hypoandrogenemia with IA and LC-MS/MS, respectively. Considering LC-MS/MS as the reference method, sensitivity and specificity of IA were 91.4% (95% CI 82.3-96.8) and 61.1% (95% CI 54.0-67.8), respectively. IA presented an AUC of 0.879 (95% CI 0.83-0.928). Multivariate regression analysis indicated that sex hormone-binding globulin (SHBG) concentrations ( = 0.002) and insulin resistance ( = 0.008) were factors associated with discrepant IA values. In conclusion, the determination of TT by IA in nondiabetic young men with obesity yields lower concentrations of TT than LC-MS/MS, resulting in an equivocal increased diagnosis of hypoandrogenemia, which could lead to inaccurate diagnosis and unnecessary treatment.
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http://dx.doi.org/10.3390/biom10121697DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7765982PMC
December 2020

Adiposity is Associated with Decreased Serum 17-Hydroxyprogesterone Levels in Non-Diabetic Obese Men Aged 18-49: A Cross-Sectional Study.

J Clin Med 2020 Nov 28;9(12). Epub 2020 Nov 28.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Málaga, Spain.

Obesity is associated with decreased circulating testosterone levels, the main male sex hormone. However, there are a number of different male sex hormones whose dynamics remain poorly understood regarding this pathology. In this regard, 17 hydroxyprogesterone (17-OH progesterone), as an important precursor of testosterone synthetized in testes and adrenal glands, could play an essential role in testosterone deficiency in male obesity. Moreover, similarly to testosterone, 17-OH progesterone could be closely associated with visceral fat distribution and metabolic dysfunction. Thus, the aim of this study was to assess serum 17-OH progesterone levels in non-diabetic obese young men and to evaluate their relationship with clinical, analytical, and anthropometric parameters. We conducted a cross-sectional study including 266 non-diabetic men with obesity (BMI ≥ 30 kg/m) aged 18-49 years; 17-OH progesterone and total testosterone (TT) were determined by high-performance liquid chromatography mass spectrometry. 17-OH progesterone levels were significantly lower in tertile 3 of body fat percentage in comparison with tertile 1 (0.74 ng/mL vs. 0.94 ng/mL, < 0.01; Bonferroni correction) and in comparison with tertile 2 (0.74 ng/mL vs. 0.89 ng/mL, = 0.02; Bonferroni correction). 17-OH progesterone levels correlated negatively with weight, BMI, waist circumference, insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and visceral fat, and positively with TT, free testosterone (FT), luteinizing hormone, and fat-free mass percentage. Multivariate linear-regression analysis showed that body fat percentage and HOMA-IR were inversely associated with 17-OH progesterone levels, while FT and ACTH were positively linked to circulating 17-OH progesterone levels. In conclusion, in a population of non-diabetic obese young men, 17-OH progesterone levels were inversely associated with adiposity. Body fat percentage and insulin resistance were negatively related to 17-OH progesterone levels, whereas FT and ACTH levels were positively associated with 17-OH progesterone levels.
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http://dx.doi.org/10.3390/jcm9123873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760398PMC
November 2020

Differential Microbial Pattern Description in Subjects with Autoimmune-Based Thyroid Diseases: A Pilot Study.

J Pers Med 2020 Oct 26;10(4). Epub 2020 Oct 26.

Unidad de Gestión Clínica de Endocrinología y Nutrición, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Clínico Virgen de la Victoria, 29010 Málaga, Spain.

The interaction between genetic susceptibility, epigenetic, endogenous, and environmental factors play a key role in the initiation and progression of autoimmune thyroid diseases (AITDs). Studies have shown that gut microbiota alterations take part in the development of autoimmune diseases. We have investigated the possible relationship between gut microbiota composition and the most frequent AITDs. A total of nine Hashimoto's thyroiditis (HT), nine Graves-Basedow's disease (GD), and 11 otherwise healthy donors (HDs) were evaluated. 16S rRNA pyrosequencing and bioinformatics analysis by Quantitative Insights into Microbial Ecology and Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) were used to analyze the gut microbiota. Beta diversity analysis showed that gut microbiota from our groups was different. We observed an increase in bacterial richness in HT and a lower evenness in GD in comparison to the HDs. GD showed a significant increase of , and compared to HDs and the core microbiome features showed that and characterized this group. was increased in HT and was part of their core microbiome. , and were greater in HT compared to GD. Core microbiome features of HT were represented by , , , and . decreased in both AITDs compared to HDs. PICRUSt analysis demonstrated enrichment in the xenobiotics degradation, metabolism, and the metabolism of cofactors and vitamins in GD patients compared to HDs. Moreover, correlation studies showed that some bacteria were widely correlated with autoimmunity parameters. A prediction model evaluated a possible relationship between predominant concrete bacteria such as an unclassified genus of , and in AITDs. AITD patients present altered gut microbiota compared to HDs. These alterations could be related to the immune system development in AITD patients and the loss of tolerance to self-antigens.
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http://dx.doi.org/10.3390/jpm10040192DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712884PMC
October 2020

Relationship between environmental temperature and the diagnosis and treatment of gestational diabetes mellitus: An observational retrospective study.

Sci Total Environ 2020 Nov 16;744:140994. Epub 2020 Jul 16.

Department of Endocrinology and Nutrition, Virgen de la Victoria Universitary Hospital, Malaga, Spain.

Introduction: Environmental temperature has been described to affect plasma glucose levels after oral glucose tolerance testing (OGTT).

Aims: We evaluated the relationship between seasons and environmental temperature and gestational diabetes mellitus (GDM) diagnosis and treatment.

Methods: We analyzed data from 2374 women retrospectively. GDM was diagnosed in 473 patients by a 100-g OGTT. OGTT results and needing of insulin therapy were evaluated in relation to seasons and environmental temperature (mean temperature and temperature change) the day of the OGTT and the preceding 14 and 28 days.

Results: We found significant seasonal differences in the percentage of GDM: 24.4% in summer vs. 15.6% in autumn (p < 0.01). The odds ratio (OR) for being diagnosed with GDM was 1.78 in summer relative to autumn, after controlling for age. A higher mean temperature the day of the OGTT and the preceding 14 and 28 days increased the risk of being diagnosed with GDM the months in which temperature was rising (March-August) but not the months in which temperature was decreasing (September-February). We observed a negative correlation between temperature and fasting glucose and a positive correlation with post-load glucose. Neither the season nor the environmental temperature affected the risk of requiring insulin therapy.

Conclusions: There is a higher prevalence of GDM diagnosis at warmer seasons and at rising temperatures the 2-4 weeks prior to the OGTT. The impact of temperature is different between fasting and post-load glucose.
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http://dx.doi.org/10.1016/j.scitotenv.2020.140994DOI Listing
November 2020

Relationship of Zonulin with Serum PCSK9 Levels after a High Fat Load in a Population of Obese Subjects.

Biomolecules 2020 05 11;10(5). Epub 2020 May 11.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Malaga, Spain.

Despite the fact that circulating levels of proprotein convertase subtilisin/kexin type 9 (PCSK9) remain unchanged after fat load in healthy lean individuals, PCSK9 has been suggested to have a role in postprandial lipemia regulation in obese individuals. On the other hand, intestinal permeability and endotoxemia have been observed to increase more in obese individuals than in non-obese individuals after a lipid load. This study aimed to analyze the relationship between PCSK9, intestinal permeability, and endotoxemia after a high fat load in obese individuals. We included 39 individuals with morbid obesity. Serum PCSK9 levels, intestinal permeability marker (zonulin), endotoxemia markers (LPS and LBP), and lipid parameters were measured before and after 3 h of fat load. A significant rise in triglycerides, apolipoprotein A1, zonulin, LPS, and LBP, and a significant decline in PCSK9, were observed after a lipid load. Linear regression analysis showed that low-density lipoprotein cholesterol (LDL-C) was independently related to PCSK9 at baseline, whereas both zonulin and LDL-C were independently related to PCSK9 levels after fat load. A relationship between zonulin and PCSK9 levels after fat load in individuals with morbid obesity may exist.
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http://dx.doi.org/10.3390/biom10050748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7277403PMC
May 2020

Efficacy of Low-Dose Radioiodine Ablation in Low- and Intermediate-Risk Differentiated Thyroid Cancer: A Retrospective Comparative Analysis.

J Clin Med 2020 Feb 21;9(2). Epub 2020 Feb 21.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Málaga, Spain.

(1) Background-low-dose radioiodine ablation is an accepted strategy for the treatment of low- and intermediate-risk thyroid carcinomas, although there is no international consensus. The aim of this study is to describe the clinical experience with low-dose radioiodine ablation in patients with low- and intermediate-risk thyroid cancer compared to high-dose ablation. (2) Methods-174 patients with low- and intermediate-risk thyroid cancer, 90 treated with low-dose ablation and 84 treated with high-dose ablation, were included. The primary endpoint was response to treatment one year after ablation, defined by stimulated thyroglobulin, whole body scan and ultrasound imaging. (3) Results-an excellent response rate of 79.8% in the low-dose group and 85.7% in the high-dose group was observed ( = 0.049). Stimulated thyroglobulin at the moment of ablation ( = 0.032) and positive antithyroglobulin antibodies ( < 0.001) were independent predictive factors for nonexcellent response. Young age ( = 0.023), intermediate initial recurrence risk ( < 0.001) and low-dose ablation ( = 0.004) were independent predictive factors for recurrence. (4) Conclusion-low-dose ablation seemed to be less effective than high-dose ablation, especially in those patients with positive antithyroglobulin antibodies or higher stimulated thyroglobulin levels at the moment of ablation. Low dose was associated with higher recurrence rates, and lower age and intermediate initial recurrence risk were independent risk factors for recurrence in our sample.
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http://dx.doi.org/10.3390/jcm9020581DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074446PMC
February 2020

Clinical and Ultrasound Thyroid Nodule Characteristics and Their Association with Cytological and Histopathological Outcomes: A Retrospective Multicenter Study in High-Resolution Thyroid Nodule Clinics.

J Clin Med 2019 Dec 9;8(12). Epub 2019 Dec 9.

Department of Endocrinology and Nutrition, Instituto de Investigación Biomédica de Málaga (IBIMA), Virgen de la Victoria University Hospital, 29010 Málaga, Spain.

Introduction: Thyroid nodules are a common finding. A high-resolution thyroid nodule clinic (HR-TNC) condenses all tests required for the evaluation of thyroid nodules into a single appointment. We aimed to evaluate the clinical outcomes at HR-TNCs.

Design And Methods: A retrospective cross-sectional multicenter study including data from four HR-TNCs in Spain. We evaluated fine-needle aspiration (FNA) indications and the association between clinical and ultrasound characteristics with cytological and histopathological outcomes.

Results: A total of 2809 thyroid nodules were included; FNA was performed in 82.1%. Thyroid nodules that underwent FNA were more likely larger, isoechoic, with microcalcifications, and in younger subjects. The rate of nondiagnostic FNA was 4.3%. A solid component, irregular margins or microcalcifications, significantly increased the odds of Bethesda IV-V-VI (vs. Bethesda II). Irregular margins and a solid component were independently associated with increased odds of malignancy. Thyroid nodules <20 mm and ≥20-<40 mm had a 6.5-fold and 3.3-fold increased risk for malignancy respectively in comparison with those ≥40 mm.

Conclusion: In this large multicenter study, we found that the presence of a solid component and irregular margins are factors independently related to malignancy in thyroid nodules. Since nodule size ≥40 mm was associated with the lowest odds of malignancy, this cut-off should not be a factor leading to indicate thyroid surgery. HR-TNCs were associated with a low rate of nondiagnostic FNA.
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http://dx.doi.org/10.3390/jcm8122172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6947274PMC
December 2019

Monoamino oxidase alleles correlate with the presence of essential hypertension among hypogonadic patients.

Mol Genet Genomic Med 2020 01 19;8(1):e1040. Epub 2019 Nov 19.

Department of Surgery, Biochemistry and Immunology, School of Medicine, University of Malaga, Málaga, Spain.

Background: Monoamine oxidase (MAO) activity has been traditionally implicated in blood pressure through its effects on biogenic amine levels such as catecholamines, serotonin, and dopamine. Nowadays, this role is considered relegated to side-effects such as orthostatic hypotension and/or hypertensive crisis derived from MAO-inhibitory treatments in patients with psychiatric disease.

Methods: In the present work we have found an association between a polymorphic variant of MAOB gene and arterial hypertension in obese hypogonadic patients. The study cases comprised a series of 219 nondiabetic males with a body mass index ≥30 kg/m and aged <45 years. Hypogonadism was defined as subnormal testosterone concentrations, when free testosterone values ranged <65 pg/ml.

Results: MAOB rs3027452-A allele carriers were significantly over-represented among hypertensive (HT) patients (25.49%) in comparison to either the non-HT patients (10%, OR = 3.079 CI [1.364-6.952], p = .005, Chi-square test) and the control population series of nonobese nor hypogonadic males (also 10%, p = .003 Chi-square test). Upon adjusted, an independent association was shown with the hypogonadic group with hypertension when compared with nonhypertensive hypogonadics (Beta = 3.653, p = .005). When quantitative analysis was performed, hypertensive patients harboring rs3027452-A allele showed higher systolic blood pressure values (p = .038, Mann-Whitney U-test) as well as an increased Systolic-Diastolic range despite following HT treatment (∆mmHg 54 vs. 48 for rs3027452-A and rs3027452-G respectively, p-value .019, Mann-Whitney U-test). Previous studies on MAOB revealed that rs3027452-A allele has been correlated to a lower activity of the enzyme, what gives a functional evidence over our observation.

Conclusion: If this result could be extrapolated to other hypertensive patient groups, it would implicate a review of the markers and therapeutic targets on human hypertension.
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http://dx.doi.org/10.1002/mgg3.1040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978270PMC
January 2020

Prevalence of and risk factors for erectile dysfunction in young nondiabetic obese men: results from a regional study.

Asian J Androl 2020 Jul-Aug;22(4):372-378

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital (IBIMA), Málaga University, Málaga 29010, Spain.

Erectile dysfunction (ED), a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. In this study, we aimed to determine the prevalence of ED and evaluate the associated risk factors in a cohort of 254 young (18-49 years) nondiabetic obese (body mass index [BMI] ≥ 30 kg m) men from primary care. Erectile function (International Index of Erectile Function [IIEF-5] questionnaire), quality of life (Aging Males' Symptoms [AMS scale]), and body composition analysis (Tanita MC-180MA) were determined. Total testosterone was determined using high-performance liquid chromatography-mass spectrometry. Multivariate logistic regression analysis was used to study the factors associated with ED. ED prevalence was 42.1%. Subjects with ED presented higher BMI, waist circumference, number of components of the metabolic syndrome, AMS score, insulin resistance, and a more unfavorable body composition than those without ED. Multivariate logistic regression analysis showed that a pathological AMS score (odds ratio [OR]: 4.238, P < 0.001), degree of obesity (BMI ≥ 40 kg m, OR: 2.602, P = 0.005, compared with BMI 30-34.9 kg m), high-density lipoprotein (HDL)-cholesterol levels (OR: 0.956, P = 0.004), and age (OR: 1.047, P = 0.016) were factors independently associated with ED. In conclusion, we demonstrate that, in a primary care-based cohort of nondiabetic young obese men, ED affected >40% of subjects. A pathological AMS score, the degree of obesity, and age were positively associated with ED, while elevated HDL-cholesterol levels were inversely associated with the odds of presenting ED. Further prospective studies are needed to evaluate the long-term consequences of ED in this population.
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http://dx.doi.org/10.4103/aja.aja_106_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406095PMC
October 2019

Cross-Sectional, Primary Care-Based Study of the Prevalence of Hypoandrogenemia in Nondiabetic Young Men with Obesity.

Obesity (Silver Spring) 2019 10 14;27(10):1584-1590. Epub 2019 Aug 14.

Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Malaga, Spain.

Objective: Obesity-associated hypoandrogenemia is increasing in parallel to the obesity epidemic. The prevalence of hypoandrogenemia in nondiabetic young men with obesity is not known. This study aimed to evaluate the prevalence of hypoandrogenemia and associated risk factors in this population.

Methods: This cross-sectional study included 266 nondiabetic men < 50 years of age with obesity who were referred from primary care. Total testosterone (high-performance liquid chromatography mass spectrometry), sex hormone-binding globulin, free testosterone (FT), luteinizing hormone (LH), high-sensitivity C-reactive protein, and homeostatic model assessment of insulin resistance were determined. Body composition and erectile function were also assessed. Hypoandrogenemia was defined as FT level < 70 pg/mL.

Results: Subnormal FT concentrations were found in 25.6% of participants. Hypoandrogenemia prevalence was different along the BMI continuum, being > 75% in individuals with BMI ≥ 50 kg/m . A multivariate regression analysis indicated that increasing BMI (P < 0.001), age (P = 0.049), and reduced LH levels (P = 0.003) were independent risk factors for hypoandrogenemia.

Conclusions: In a primary care-based cohort of nondiabetic young men with obesity, hypoandrogenemia was a very prevalent finding and was directly associated with adiposity. Obesity, age, and reduced LH levels were independent risk factors associated with hypoandrogenemia. Further prospective studies are needed to evaluate the long-term consequences of hypoandrogenemia in this population.
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http://dx.doi.org/10.1002/oby.22579DOI Listing
October 2019

Effects of SHBG rs1799941 Polymorphism on Free Testosterone Levels and Hypogonadism Risk in Young Non-Diabetic Obese Males.

J Clin Med 2019 Jul 31;8(8). Epub 2019 Jul 31.

Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, 29010 Málaga, Spain.

Introduction: Obesity has been associated with increased risk of presenting hypogonadism. Free testosterone (FT) is the fraction of testosterone that carries out the biological function of testosterone, and is determined from total testosterone (TT) and sex-hormone binding globulin (SHBG) levels. We aimed to study the SHBG polymorphism rs1799941 in a cohort of young non-diabetic obese males to unravel the possible implication of this polymorphism in obesity-related hypogonadism.

Methodology: 212 young (<45 years) non-diabetic obese (BMI ≥ 30 kg/m) males participated in this study. Subjects were classified according to TT and FT levels in: Eugonadal ( 55, TT > 3.5 ng/mL and FT ≥ 70 pg/mL; EuG), normal FT hypogonadism ( 40, TT < 3.5 and FT ≥ 70 pg/mL; normal FT HG) and hypogonadism ( 117, TT < 3.5 ng/mL and TL < 70 pg/mL; HG). The SHBG rs1799941 polymorphism (GG/GA/AA) was analyzed using the Taqman Open Array (Applied biosystem).

Results: The rs1799941 frequencies were different among the groups. Higher proportion of the allele (A) was found in HG, compared to EuG and normal FT HG. Among the genotypes, the rare homozygous (AA) were found in the normal FT HG group and higher levels of serum SHBG and lower of FT were observed. The presence of the allele A was related (according to lineal regression models) to an increased of SHBG levels ((GA) β = 3.28; (AA) β = 12.45) and a decreased of FT levels ((GA) β = -9.19; (AA) β = -18.52). The presence of the allele (A) increased the risk of presenting HG compared to normal FT HG (OR = 2.54).

Conclusions: The rs1799941 of the SHBG gene can partially determine the presence of obesity-related hypogonadism in young non-diabetic males and whether these subjects have normal FT HG.
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http://dx.doi.org/10.3390/jcm8081136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6722847PMC
July 2019

Prevalence of postprandial hyperglycaemia in basal insulin-treated patients with type 2 diabetes mellitus with controlled fasting glycaemia and elevated glycosylated haemoglobin.

Diabetol Metab Syndr 2019 24;11:59. Epub 2019 Jul 24.

5Hospital Universitario Regional, Servicio de Medicina Interna, FIMABIS, Málaga, Spain.

Objective: To study the prevalence of postprandial hyperglycaemia (PPH) in type 2 diabetes mellitus (T2DM) patients treated with basal insulin, having fasting glucose < 130 mg/dL but HbA1c > 7.0% (53 mmol/mol).

Methods: This was an observational prospective multicentric study conducted in Spain. During 2 weeks, patients recorded a 6-point self-measured blood glucose profile (before and 2 h after eating) every 2 days. PPH was defined according to IDF and ADA guidelines (> 160 and > 180 mg/dL, respectively).

Results: We included 98 patients (males: 56.1%; mean age: 64.3 ± 10.4 years) who were treated with basal insulin for at least 1 year at stable doses in the last 2 months, 88.8% of them received concomitant oral antidiabetic drugs. Overall, 95.7% (95% CI 91.6-99.8) and 93.5% (95% CI 88.6-98.5) of patients showed ≥ 1 episode of PPH according to IDF and ADA criteria respectively. PPH was more frequently observed after lunch and dinner. The proportion of patients with ≥ 40% readings in range of PPH was 59.1% (95% CI 49.1-69.1) and 40.9% (95% CI 30.9-50.9), according to IDF and ADA criteria, respectively.

Conclusions: PPH is very common and should be considered a priority target in basal insulin-treated T2DM patients with elevated HbA1c despite controlled fasting glucose.
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http://dx.doi.org/10.1186/s13098-019-0452-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6657157PMC
July 2019

New molecular biomarkers in differentiated thyroid carcinoma: Impact of miR-146, miR-221 and miR-222 levels in the evolution of the disease.

Clin Endocrinol (Oxf) 2019 07 14;91(1):187-194. Epub 2019 Apr 14.

Endocrinology and Nutrition Unit, Virgen de la Victoria University Hospital, Campus Universitario Teatinos SN, Málaga, Spain.

Objective: MircroRNAs (miR) are small, noncoding RNA molecules of 18-25 nucleotides. Their dysregulation has been widely studied in many human tumours including differentiated thyroid cancer (DTC). miRs more frequently associated with these kinds of tumours are miR-146, miR-221 and miR-222. Our objective was to assess the relationship among circulating miR levels and the evolution and outcomes of disease.

Design: We analysed a sample of 60 patients with DTC assigning them to one of three groups according to the dynamic scale of risk (excellent response, incomplete biochemical response and incomplete structural response).

Patients And Measurements: At study inclusion, we determined thyroid-stimulating hormone, thyroxine, thyroglobulin, antithyroglobulin antibodies and plasma levels of miR-146, miR-221 and miR-222.

Results: Male sex and advanced age at diagnosis were associated with the worst disease progression. miR-222 was twofold to threefold higher in tall cell papillary carcinomas (P = 0.038). miR-146 (P = 0.016) and miR-221 (P = 0.050) had a positive correlation with thyroglobulin at the time of sampling. In regression analysis, miR-146 (P = 0.006), miR-221 (P = 0.004) and miR-222 (P = 0.007) predicted more than 70% of the variation in thyroglobulin levels at the time of sampling.

Conclusions: Elevated miR-222 and miR-146 levels are associated with poorer outcomes of the disease and may have a prognostic value in the management and follow-up of DTC.
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http://dx.doi.org/10.1111/cen.13972DOI Listing
July 2019

The safety of DPP-4 inhibitor and SGLT2 inhibitor combination therapies.

Expert Opin Drug Saf 2018 08 12;17(8):815-824. Epub 2018 Jul 12.

a Unidad de Gestión Clínica de Endocrinología y Nutrición , Hospital Universitario Virgen de la Victoria , Málaga , Spain.

Introduction: Type 2 diabetes (T2D), a multifactorial and chronic disease, requires in an elevated percentage of patients the association of several antidiabetic drugs to achieve optimal glycemic control. Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter inhibitors (SGLT2i) are new classes of oral antidiabetic drugs developed over the last years.

Areas Covered: This paper summarizes the safety of DPP-4i and SGLT2i combination therapies. Relevant studies were identified through searches in PubMed.

Expert Opinion: DPP4i and SGLT2i are antidiabetic drugs that lower blood glucose without causing hypoglycaemia or weight increase. More importantly, cardiovascular trials have clearly demonstrated the cardiovascular safety of DPP4i and a reduction in cardiovascular events with SGLT2i (empagliflozin and canagliflozin). Therefore, the association of both therapeutic groups could be an attractive option to achieve optimal blood glucose control in T2D because of their complementary mechanism of action. Clinical trials evaluating the combination of SGLT2i and DPP4i show that the co-administration of these drugs in fixed-dose combinations in comparison to separate tablets does not carry additional safety concerns that each individual drug, but increases therapeutic effects. Therefore, this antidiabetic combination is a safe and effective therapy for patients with T2D.
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http://dx.doi.org/10.1080/14740338.2018.1497158DOI Listing
August 2018

Secondary male hypogonadism: A prevalent but overlooked comorbidity of obesity.

Asian J Androl 2018 Nov-Dec;20(6):531-538

Department of Endocrinology and Nutrition, Virgen de la Victoria Universitary Hospital, Malaga 29010, Spain.

Male hypogonadism associated with obesity is a very prevalent condition and is increasing in parallel with the epidemic prevalence of obesity. Low testosterone levels promote higher fat mass with reduced lean mass. Male hypogonadism is related to an increase in associated cardiometabolic complications, such as hypertension, type 2 diabetes mellitus, the metabolic syndrome, and cardiovascular disease. Its influence as a comorbidity of obesity is becoming more evident and should be evaluated and treated in at-risk patients. Mechanisms involved in this relationship include body composition changes, the presence of adipokines, insulin resistance, and other factors, some of which are still unknown. Weight loss and treatment to replace testosterone levels improve the metabolic profile and quality of life in patients with obesity and hypogonadism; these beneficial effects depend on treatment modality and duration of therapy. The use of testosterone replacement therapy may be indicated, as it has not been shown to increase cardiovascular risk, and retrospective studies suggest a reduction in events in men with metabolic syndrome and type 2 diabetes.
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http://dx.doi.org/10.4103/aja.aja_44_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219298PMC
October 2019

Hyperphagia and Obesity in Prader⁻Willi Syndrome: Deficiency and Beyond?

Genes (Basel) 2018 Jun 7;9(6). Epub 2018 Jun 7.

Laboratory of Biochemical Neuroendocrinology, Department of Human Genetics, KU Leuven, B-3000 Leuven, Belgium.

Prader⁻Willi syndrome (PWS) is a complex genetic disorder that, besides cognitive impairments, is characterized by hyperphagia, obesity, hypogonadism, and growth impairment. Proprotein convertase subtilisin/kexin type 1 () deficiency, a rare recessive congenital disorder, partially overlaps phenotypically with PWS, but both genetic disorders show clear dissimilarities as well. The recent observation that is downregulated in a model of human PWS suggests that overlapping pathways are affected. In this review we will not only discuss the mechanisms by which PWS and deficiency could lead to hyperphagia but also the therapeutic interventions to treat obesity in both genetic disorders.
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http://dx.doi.org/10.3390/genes9060288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027271PMC
June 2018

Pharmacokinetic drug evaluation of exenatide for the treatment of type 2 diabetes.

Expert Opin Drug Metab Toxicol 2018 02 28;14(2):207-217. Epub 2017 Dec 28.

a Department of Endocrinology and Nutrition , Virgen de la Victoria Hospital, Málaga University (IBIMA). , Málaga , Spain.

Introduction: Glucagon-like peptide-1 (GLP-1) receptor analogs are a group of therapeutic agents which mimic endogenous GLP-1, exerting their effect by the stimulation of the GLP-1 receptor with a wide distribution. Its activation increases insulin releasing dependent on blood glucose levels, suppression of glucagon secretion and a reduction of hepatic glucose output. It delays gastric emptying and increases satiety. Exenatide is the synthetic version of exendin-4, a natural peptide with similar properties to human GLP-1. There are two pharmaceutical forms, for subcutaneous injection: twice daily and once weekly. Clinical practice guidelines recommend them because of a high efficacy reducing hyperglycemia, low risk of hypoglycemia and a significative weight loss effect. Gastrointestinal adverse events are the most common beside injection site-related. Their cost is the main limitation to use. Areas covered: We review the recent literature investigating the pharmacokinetics and pharmacodynamics and efficacy-safety studies of exenatide twice daily and once weekly in type 2 diabetes Expert opinion: GLP-1 receptor analogs are now positioned as an effective and safe drug for the treatment of type 2 diabetes. Exenatide significally reduces HbA1c and fasting plasma glucose. Additionally, it produces moderate weight loss and decreases blood pressure. One weekly formulation may improve compliance while cost is still a limitation. EXSCEL trial has shown that, despite cardiovascular safety, exenatide do not exhibits cardiovascular benefits.
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http://dx.doi.org/10.1080/17425255.2018.1420160DOI Listing
February 2018

Adherence and tolerance as key in brake on weight loss in cancer patients with nutritional risk after intervention with a high calorie nutritional and specific hyperproteic supplement

Nutr Hosp 2017 06 5;34(3):524-531. Epub 2017 Jun 5.

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Background: In patients with nutritional risk, the European Society for Clinical Nutrition and Metabolism (ESPEN) recommends nutritional supplements during cancer treatment to prevent weight loss. Objectives: Our goal is to determine the acceptability, compliance and tolerance of a hyperproteic, high-calorie, omega-3 enriched supplement in cancer patients. Methods: Unicentric, prospective observational study in cancer patients with hyperproteic, high-calorie, rich in omega 3 and low volume nutritional supplement. Thirty patients with malnutrition or risk of malnutrition were included. Supplementation lasted six days. Compliance (packaging used), acceptability (Madrid scale), anthropometric variables and gastrointestinal adverse events (AEs) were evaluated. Results: Seventy per cent were men, with an average age of 60 years (range 32-79), with lung (43.3%), ENT (26.7%) and breast neoplasms (13.3%), stage III-IV (56.7%), and treated with radiotherapy (93.3%), chemotherapy (60%) and surgery (16.7%). The product was accepted by all patients. A compliance rate of 100% was observed. Gastrointestinal AE (grade II) related to the supplement was observed in two patients (6.7%). Both subjects had previous gastrointestinal diseases. The median weight, body mass index (BMI) and protein intake increased during supplementation (0.2 kg, 0.1 kg/m2 and 6.2 g). No differences were observed regarding calorie, fat and carbohydrates intake. Conclusion: The high acceptance and compliance with the specific nutritional supplement was associated with an improved nutritional status for cancer patients, and reversed the weight loss without severe gastrointestinal problems, or producing intake displacement.
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http://dx.doi.org/10.20960/nh.1331DOI Listing
June 2017

How Can a Good Idea Fail? Basal Insulin Peglispro [LY2605541] for the Treatment of Type 2 Diabetes.

Diabetes Ther 2017 Feb 28;8(1):9-22. Epub 2016 Nov 28.

Department of Endocrinology and Nutrition, Virgen de la Victoria Universitary Hospital, Malaga, Spain.

Introduction: Lack of control in diabetic patients has stimulated the development of new insulin analogues. One of these was basal insulin peglispro (BIL) or LY2605541; it had a large hydrodynamic size, flat pharmacokinetic profile, half life of 2-3 days and acted preferably in the liver.

Methods: We reviewed the recent literature examining the pharmacokinetics, pharmacodynamics, efficacy and safety of BIL treatment in type 2 diabetes patients.

Results: The pharmacodynamic and pharmacokinetic outline of BIL seemed to have an advantage over neutral protamine Hagedorn and glargine insulins. Recently, phase 3 studies suggested BIL was superior to glargine in reducing glucose levels in type 1 and type 2 diabetes patients in addition to causing less weight gain. It showed a different hypoglycaemia rate profile depending on the study population, with less nocturnal hypoglycaemia compared to glargine. Unfortunately, it caused higher transaminase and triglyceride levels, which led the company to discontinue development. The decision came after it had been analysed by the regulatory authorities and other external experts concerning the worse liver profile data from the IMAGINE trials.

Conclusions: BIL was an adequate basal insulin analogue with interesting specific properties. Unfortunately the disadvantages as shown in the lipid values and liver function tests led to its failure.
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http://dx.doi.org/10.1007/s13300-016-0214-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5306113PMC
February 2017

[Cushing's syndrome in a patient with macronodular adrenal hyperplasia secondary to aberrant hormone receptors].

Med Clin (Barc) 2016 09 13;147(5):226-227. Epub 2016 May 13.

Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario Virgen de la Victoria, Málaga, España.

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http://dx.doi.org/10.1016/j.medcli.2016.03.026DOI Listing
September 2016