Publications by authors named "Sara Pascoe-González"

12 Publications

  • Page 1 of 1

Administration of Herbarium Mixture () on Metabolic Profile in Type 2 Diabetes Mellitus Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.

J Med Food 2021 May 21;24(5):527-532. Epub 2020 Sep 21.

Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.

The use of herbarium mixture has been empirical, and the properties are not yet known. The aim of this study was to evaluate the effect of oral administration of herbarium mixture () on metabolic profile in patients with type 2 diabetes mellitus (T2DM). A randomized, double-blind, placebo-controlled, clinical trial was carried out in 40 patients with T2DM. They were between 40 and 65 years of age, with body mass index (BMI) between 25.0 and 34.9 kg/m and HbA1c >7.0%. BMI, waist circumference, fasting glucose, HbA1c, lipids, kidney, and liver function were measured. The patients were randomly assigned to receive the herbarium mixture () 400 mg before each meal, or placebo for 90 days. Herbarium mixture group showed decreased waist circumference (99 ± 14 vs. 98 ± 15 cm;  = .019), fasting glucose (12.0 ± 5.7 vs. 10.3 ± 5.1 mM;  = .019), and HbA1c (9.9% ± 2.7% vs. 8.9% ± 2.5%,  = .002). In conclusion, the administration of herbarium mixture () improved the glycemic profile in patients with T2DM. ClinicalTrial registration: NCT03313856 ClinicalTrials.gov.
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http://dx.doi.org/10.1089/jmf.2020.0082DOI Listing
May 2021

Effect of green tea extract on arterial stiffness, lipid profile and sRAGE in patients with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled trial.

Int J Food Sci Nutr 2019 Dec 14;70(8):977-985. Epub 2019 May 14.

Department of Physiology, Pharmacology, Health Sciences University Center, University of Guadalajara , Guadalajara , Mexico.

Type 2 diabetes mellitus (T2DM) is associated with premature atherosclerosis and arterial stiffening due to the accumulation of advanced glycation end-products in vessel walls. Green tea polyphenols are considered cardio-protective substances. In this randomised double-blind placebo-controlled trial (NCT02627898), we evaluated the effect of Green tea extract on arterial stiffness parameters, lipids, body composition and sRAGE levels. Twenty normotensive patients with T2DM treated with the standard therapy and statins, mean age 53.2 ± 9.4 years and mean BMI 30.1 ± 4.5 kg/m, were randomised to receive a daily dose of 400 mg of green tea extract (polyphenols ≥90%, EGCG ≥45%) or placebo for 12 weeks. Compared to placebo, administration of green tea extract decreased central augmentation index (-3.05 ± 10.8% vs. 6.7 ± 0.1%,  = .04). These findings suggest that green tea extract could be used as an adjunct to the standard therapy to improve arterial stiffness in T2DM.
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http://dx.doi.org/10.1080/09637486.2019.1589430DOI Listing
December 2019

Efficacy and safety of the combination of isosorbide dinitrate spray and chitosan gel for the treatment of diabetic foot ulcers: A double-blind, randomized, clinical trial.

Diab Vasc Dis Res 2018 07 23;15(4):348-351. Epub 2018 Apr 23.

1 Instituto de terapéutica experimental y clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Mexico.

Aim: To evaluate whether a combination of isosorbide dinitrate spray and chitosan gel (10%) topically applied can have additive benefits for management of diabetic foot ulcers.

Methods: In a randomized, placebo-controlled, double-blinded clinical trial, 68 patients were divided into four groups: Group 1: treated with chitosan gel; Group 2: isosorbide dinitrate spray; Group 3: combination of isosorbide dinitrate spray and chitosan gel; Group 4: placebo.

Results: Histological analyses showed a significant regeneration in all groups ( p < 0.001). On the final assessment of the ulcer, using the combination was found a wound closure percentage of 71 ± 30, 70 ± 27 using isosorbide dinitrate, 58 ± 30 with chitosan and 50 ± 16 with placebo. The number of patients who achieved complete ulcer closure was six using the combination, four with isosorbide dinitrate, three with chitosan and one with placebo. The progression in the healing process of the ulcer showed marked inmunohistochemical differences of Von Willebrand Factor, desmin, vascular endothelial growth factor-A and α-smooth muscle actin in all groups ( p < 0.001), but without notable differences between them.

Conclusion: The combination was better than placebo to reduce the dimensions of the ulcer, accelerate healing and increase the number of patients who achieved complete closure of the ulcer, but the combination was not better than chitosan or isosorbide dinitrate used separately.
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http://dx.doi.org/10.1177/1479164118769528DOI Listing
July 2018

Effect of Alpha-Lipoic Acid on Clinical and Neurophysiologic Recovery of Carpal Tunnel Syndrome: A Double-Blind, Randomized Clinical Trial.

J Med Food 2018 May 22;21(5):521-526. Epub 2018 Jan 22.

1 Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara , Guadalajara, Jalisco, México .

The objective of our study was to examine the effect of alpha-lipoic acid (ALA) on clinical and neurophysiologic outcomes after surgery for idiopathic carpal tunnel syndrome (CTS). We conducted a randomized, double-blind, placebo-controlled clinical trial in 20 adults diagnosed with idiopathic CTS after clinical and neurophysiologic assessment. Eligible participants took 600 mg ALA or placebo per day for 1 month before surgery, and for 2 months afterward. Further clinical and neurophysiologic assessments were undertaken immediately before surgical decompression, and at 12 weeks postoperatively with additional clinical assessments at the 4th and 8th week after surgery. Clinical outcome measures were taken by Boston Questionnaire score, the presence or absence of Tinel's sign, and Phalen's test findings. Median nerve conduction studies were also undertaken and interpreted according to Dumitru's reference values. Nineteen patients completed the study; one member of the placebo group was lost during follow-up. There were significant improvements in clinical and neurophysiologic variables in the ALA treatment group, present even before surgery. Boston Questionnaire scores had improved significantly in both groups. In the ALA group, none of the participants had positive Phalen's or Tinel's signs at 12 weeks, and motor and sensory fiber latency and amplitude had significantly improved; in the placebo group, only the sensory distal latency had improved significantly. In conclusion, ALA administered 1 month before open decompression and for 2 months afterward improves the clinical and neurophysiologic outcomes after surgery.
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http://dx.doi.org/10.1089/jmf.2017.0056DOI Listing
May 2018

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.

Arch Cardiol Mex 2017 Oct - Dec;87(4):316-325. Epub 2017 Feb 10.

Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.

Objective: To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population.

Methods: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90mmHg were randomised to either 120mg FMS or 60mg FMS + 12.5mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90mmHg received 120mg FMS+12.5mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study.

Results: FMS 60mg (n=272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3±8.9 (p<.0001) and 16.0±14.1 (p<.0001)mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120mg, FMS 60mg+HCTZ 12.5mg, or FMS 120mg+HCTZ 12.5mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP<90mmHg and an SBP<140mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%).

Conclusion: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.
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http://dx.doi.org/10.1016/j.acmx.2017.01.001DOI Listing
September 2018

Serum levels of undercarboxylated osteocalcin are related to cardiovascular risk factors in patients with type 2 diabetes mellitus and healthy subjects.

World J Diabetes 2017 Jan;8(1):11-17

Sergio Sanchez-Enriquez, Isabel Thalia Ballesteros-Gonzalez, Edgar Alfonso Rivera-Leon, Juan Luis Alcala-Zermeno, Iris Monserrat Llamas-Covarrubias, Biochemistry Laboratory, Molecular Biology and Genomics Department, University Center of Health Sciences, University of Guadalajara, CP 44340 Guadalajara, Jalisco, Mexico.

Aim: To determine a potential relationship between serum undercarboxylated (ucOC) concentration and cardiovascular risk factors in type 2 diabetes (T2D) patients and healthy subjects (HS).

Methods: A cross-sectional study was conducted on 140 subjects classified into two groups, 70 with T2D and 70 HS. Medical history and physical examination with anthropometric measurements were obtained from all subjects. Body fat percentage was determined by bioelectrical impendency analysis. Serum ucOC concentration was determined by enzyme immunoassay, while serum levels of insulin and hsCRP were obtained using high sensitivity enzyme-linked immunosorbent assay. Insulin resistance was determined using the homeostasis model assessment-IR. Lipid profile [triglycerides, total cholesterol (TC), high-density lipoproteins (HDL-c), low density lipoproteins (LDL-c), very low-density lipoproteins] was determined by spectrophotometry and standard formulas when applicable.

Results: The T2D patient group showed significantly higher values of waist circumference, waist-to-hip ratio, systolic blood pressure (SBP), diastolic blood pressure (DBP), current smoking, and alcohol use when compared to the HS group ( < 0.05). We observed a significantly lower serum ucOC concentration in T2D than in HS (1.5 ± 1.4 2.3 ± 1.8, < 0.05). In the whole study population, ucOC concentration was inversely correlated with body mass index (BMI) ( = -0.236, < 0.05), fasting plasma glucose ( = -0.283, < 0.01) and HDL-c ( = -0.255, < 0.05); and positively correlated with LDL-c/HDL-c ratio ( = 0.306, < 0.05) and TC/HDL-c ratio ( = 0.284, < 0.05). In the T2D group, serum ucOC concentration was inversely correlated with BMI ( = -0.310, < 0.05) and body-fat percentage ( = -0.311, < 0.05), and positively correlated with DBP ( = 0.450, < 0.01). In HS group a positive correlation between serum levels of ucOC and SBP ( = 0.277, < 0.05) was observed.

Conclusion: Serum ucOC is a potential marker for cardiovascular risk in Mexicans because it is related to adiposity parameters, blood pressure and lipid profile.
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http://dx.doi.org/10.4239/wjd.v8.i1.11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237813PMC
January 2017

Effectiveness of degradable and non-degradable implants to close large septal perforations in an experimental model.

J Plast Surg Hand Surg 2016 Aug 16;50(4):222-6. Epub 2016 Mar 16.

a Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, CUCS , Universidad de Guadalajara , Guadalajara Jalisco , México.

Background Reparation of large nasal septum perforations continues to be challenging. Bipedicled mucoperichondrial and inter-positional grafts currently show the most promising results. New implants have emerged to be used as a support membrane to carry on the mucosal cells, taking advantage of the innate proliferative properties of the mucosal tissue. Objective To compare the effectiveness of two kinds of material; non-absorbable dimethylsiloxane (silicone elastomers) and absorbable porcine small intestinal submucosa (Surgisis), both used as an inter-positional graft without neighbouring flaps to close nasal septal perforations in an experimental model. Methods Fifteen dogs were divided into three groups. One group received Surgisis, the other sheets of dimethylsiloxane and the last group a sham group. The dogs were followed for 6 weeks. Results The initial perforation of the nasal septum showed complete mucosal closure in the dimethylsiloxane group. The Surgisis group, on the other hand, had a smaller reduction than that at the beginning (final mean area = 23.0 ± 5.4 mm(2) (p < 0.05); however, complete closure was not achieved. Sham animals showed an inconstant and slight reduction in dimension from 100 mm(2) to 70 ± 16 mm(2) of mucosa and cartilage, but closure was not achieved. A significantly higher number of capillaries were observed in the Surgisis group compared to the dimethylsiloxane group (p < 0.05) without differences in inflammation, fibrosis, or necrosis. Conclusions The non-absorbable implant; dimethylsiloxane facilitates a better closure of the nasal septum.
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http://dx.doi.org/10.3109/2000656X.2016.1152973DOI Listing
August 2016

The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study.

J Diabetes Complications 2012 Jul-Aug;26(4):352-8. Epub 2012 May 16.

Unidad de Investigación Cardiovascular, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, México.

Introduction: Diabetic polyneuropathy aetiology is based on oxidative stress generation due to production of reactive oxygen species. Ubiquinone is reduced to ubiquinol and redistributed into lipoproteins, possibly to protect them from oxidation.

Aims: To evaluate the impact of oral ubiquinone in diabetic polyneuropathy, and the role of lipid peroxidation (LPO) and nerve growth factor (NGF-β).

Methods: We conducted a double-blind, placebo-controlled clinical trial, patients were randomized to ubiquinone (400 mg) or placebo daily for 12 weeks. Main outcomes were clinical scores, nerve conduction studies, LPO, NGF-β and safety.

Results: Twenty four patients on experimental group and twenty five on control group met the inclusion criteria (mean age 56 years, 22% male and 78% female, mean evolution of type 2 diabetes mellitus 10.7 years). Significant improvement on experimental vs control group was found in neuropathy symptoms score (from 2.5 ± 0.7 to 1 ± 0.8, p<0.001), neuropathy impairment score (5.5 ± 4 to 3.1 ± 2.6, p<0.001), sural sensory nerve amplitude (13.0 ± 6.1 to 15.8 ± 5.1 μV, p=0.049), peroneal motor nerve conduction velocity (39.7 ± 5.0 to 47.8 ± 4.9 m/s, p=0.047), and ulnar motor nerve conduction velocity (48.8 ± 6.8 to 54.5 ± 6.1m/s, p=0.046). There was a significant reduction of LPO in subjects treated with ubiquinone vs placebo (16.7 ± 8.6 and 23.2 ± 15.8 nmol/mL, respectively) with p<0.05, and NGF-β did not change (control 66.5 ± 26.7 vs. experimental 66.8 ± 28.4 pg/mL, p=0.856). No drug-related adverse reactions were reported.

Conclusions: Twelve weeks treatment with ubiquinone improves clinical outcomes and nerve conduction parameters of diabetic polyneuropathy; furthermore, it reduces oxidative stress without significant adverse events.
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http://dx.doi.org/10.1016/j.jdiacomp.2012.04.004DOI Listing
January 2013

Effect of celecoxib, a cyclooxygenase-2-specific inhibitor, on insulin sensitivity, C-reactive protein, homocysteine, and metabolic profile in overweight or obese subjects.

Metab Syndr Relat Disord 2005 ;3(2):95-101

Medical Research Unit in Clinical Epidemiology, West National Medical Center, Mexican Institute of Social Security, Guadalajara, Mexico.

Background: The aim of this study was to assess the effect of celecoxib, a cyclooxygenase- 2-specific inhibitor, on insulin sensitivity, C-reactive protein, homocysteine, and metabolic profile in overweight or obese subjects.

Methods: A randomized, double-blind, placebo-controlled clinical trial was carried out on 12 overweight or obese (body mass index, 25-35 kg/m(2)) male volunteers. Six subjects received celecoxib 200 mg orally in the morning for a period of 4 weeks. Six other individuals took a placebo for the same period of time, as the control group. Before and after the 4-week study period, insulin sensitivity, C-reactive protein, homocysteine levels, and metabolic profile were estimated. To assess insulin sensitivity, the euglycemic-hyperinsulinemic clamp technique was performed.

Results: There were no significant differences in the basal measurements between both groups. C-reactive protein, homocysteine, and metabolic profile were not modified by the pharmacologic intervention with placebo or celecoxib. The insulin sensitivity after celecoxib was significantly higher compared with the basal estimation (3.8 +/- 1.2 vs. 2.8 +/- 1.2 mg/kg/min; p = 0.028). The placebo did not modify the insulin sensitivity.

Conclusions: The specific inhibition of the cyclooxygenase-2 by celecoxib increased the insulin sensitivity in overweight or obese subjects, without modification in C-reactive protein, homocysteine levels, and metabolic profile.
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http://dx.doi.org/10.1089/met.2005.3.95DOI Listing
October 2012

[Association of hyperinsulinemia with left ventricular hypertrophy and diastolic dysfunction in patients with hypertension].

Rev Med Chil 2007 Sep 15;135(9):1125-31. Epub 2007 Nov 15.

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, México.

Background: Hypertension is the main independent cardiovascular risk factor. However, there are additional factors that induce organic damage.

Aim: To assess the association between hyperinsulinemia, ventricular hypertrophy and left ventricular diastolic function.

Patients And Methods: Seventy-four patients aged 30 to 65 years, with mild or moderate systemic hypertension, with overweight or mild obesity and normal glucose tolerance curve (GTC), were studied. Serum insulin was measured during GTC. The maximum levels of insulin and glucose were observed 60 minutes after the oral glucose load and they were expressed as rG/1. Patients were stratified in three groups according to their glucose and insulin fasting levels (I0) and post-glucose challenge levels (rG/I): Group 1 (normoinsulinemic patients) I0 <17 mU/mL and rG/I >2 (2.45+0.4). Group 2 (post-prandial hyperinsulinemic patients) I0 <17 mU/mL and rG/I <2> 1 (1.34+0.3). Group 3 (persistently hyperinsulinemic patients) I0 >17 mU/mL and <1 (0.7+0.3). Left ventricular mass and its diastolic function were measured by Doppler echocardiography.

Results: No differences in blood pressure or age were observed between groups. There was a negative correlation between ventricular mass and rG/1 (r =-0.282, p =0.015). Left ventricular diastolic dysfunction was significantly more deteriorated in group 3, as compared with group 1 (p <0.001 ANOVA). There was a significant correlation between g/GI and diastolic dysfunction (r =0.232 p =0.047).

Conclusions: Fasting, post challenge hyperinsulinemia and a rG/I <1 are associated with higher ventricular mass and left ventricular diastolic dysfunction, independent of blood pressure and age.
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http://dx.doi.org/10.4067/s0034-98872007000900005DOI Listing
September 2007

Effect of tequila on homocysteine, insulin secretion, insulin sensitivity, and metabolic profile in healthy men.

J Diabetes Complications 2005 May-Jun;19(3):155-9

Medical Research Unit in Clinical Epidemiology, West National Medical Center, Mexican Institute of Social Security, Guadalajara, Mexico.

Aim: The purpose of this study is to identify the effect of a low dose of tequila on homocysteine, insulin secretion, insulin sensitivity, and metabolic profile in healthy young men.

Methods: An open clinical trial was carried out in eight healthy nonobese, young male volunteers. The study was divided in two phases. The first one evaluated metabolic changes, including insulin secretion and sensitivity due to acute administration of 30 ml of straight tequila. The second phase of the study evaluated metabolic effects due to the daily administration of 30 ml of tequila during 30 days.

Results: There were no significant metabolic changes after the single oral administration of 30 ml of straight tequila. After the administration of tequila during 30 days, a significant increase in homocysteine levels and a tendency to increase the glucose concentration and to decrease the insulin sensitivity were found.

Conclusion: Detrimental metabolic changes were observed with the daily administration of 30 ml of tequila during 30 days.
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http://dx.doi.org/10.1016/j.jdiacomp.2004.09.001DOI Listing
September 2005

Screening in clinical trials.

Lancet 2002 Sep;360(9337):952; author reply 952

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http://dx.doi.org/10.1016/S0140-6736(02)11058-0DOI Listing
September 2002