Gymnema Sylvestre vs Berberine in Obesity Gene Expression of Adipokines (GS VS BBR A)

May 18, 2024 updated by: Cindy Rodríguez Bandala, National Polytechnic Institute, Mexico

Comparative Efficacy of Gymnema Sylvestre vs Berberine in the Clinical Outcomes and Gene Expression of Adipokines in Patients With Exogenous Obesity

Obesity is a disease that affects a large part of the world's population and is a risk factor for the development of metabolic, cardiovascular, oncological, and neurodegenerative diseases. Treatments with Gymnema Sylvestre (GS) and Berberine (BBR) have been studied in metabolic diseases such as obesity and type 2 diabetes mellitus (DM2), and have gained importance in recent years, however, questions remain regarding their comparative effect on biochemical parameters, body composition and gene expression of adipokines. Methodology. We carried out a comparative study in 50 adult Mexican patients with a diagnosis of Obesity. Two groups of patients were formed: A. Treated with GS and B. Treated with BBR. Baseline and final measurements were determined 3 months after treatment. Biochemical and body composition parameters were evaluated and the gene expression of Resistin (Res), Omentin (Om), Visfatin (Vis) and Apelin (Ap) was determined, as well as safety parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial oversight A comparative, descriptive, observational, longitudinal, and prospective analysis study was carried out in the Comprehensive Obesity and Overweight Care Program at the Higher School of Medicine. This study was carried out in full accordance with good clinical practice guidelines and the Declaration of Helsinki. The study was registered with the Research and Ethics Committee of the Higher School of Medicine (ESM.CE-01/7-12-2015). All patients signed the informed consent, and the information was protected through a confidentiality letter.

Patients We included 50 Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG(kilogram)/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose < 126 mg/dL or glycated hemoglobin < 6.5%). Key exclusion criteria included (i) pregnant patients, (ii) diabetics, and (iii) patients with allergic reaction to any components of the supplements. The first study group, group A (25 patients) was treated with GS at a dose of two 200 mg capsules before breakfast, while in the second group, group B (25 patients) were treated with BBR at dose of one 500 mg tablet three times a day before each meal. In both groups, the treatment lasted 3 months.

Trial procedures and outcomes Anthropometric, physiological, and biochemical parameters were measured in two sessions, before and after treatment. The anthropometric measurements were body weight, height, waist, and hip circumference, in addition to body analysis using the Inbody 770. As a physiological measure, only blood pressure was considered using WelchAllyn brand anomanometers with cuff for obese patients. Regarding biochemical parameters, fasting glucose, lipid profile (total cholesterol, triglycerides, HDL, LDL), basal insulin and HbA1c were measured. Adherence to treatment and the presence of adverse effects was recorded using a log that indicated the time at which the tablets were ingested and whether they had any adverse effects that day.

Additionally, whole blood samples were taken from 50 patients, 25 had received treatment with GS (group A) and 25 received treatment with BBR (group B). The extraction of tRNA(transfer ribonucleic acid) was carried out using the TRIzol®Reagent technique, which consists of a mixture of guanidine isocyanate and phenol-chloroform. Once the total RNA was isolated, it was suspended in RNase-free water to avoid possible degradation of the sample before proceeding with reverse transcription. The extraction and integrity of the tRNA was verified by means of agarose gel electrophoresis. The final purity of the samples was calculated based on the absorbance obtained with a measurement at 260-280. cDNA(complementary DNA) amplification was performed using the "First Strand cDNA transcription" synthesis kit for rtPCR from Roche. A real-time polymerase chain reaction (RT-PCR) procedure was performed to determine the relative expression of the mRNA(messenger ribonucleic acid) of the genes studied, using probes from the human transcriptome library (Human Universal Probe Library), a LightCycler nano thermocycler and a TaqMan type reaction mixture, all from the Roche Diagnostics brand (Roche Diagnostics GmbH(Gesellschaft mit beschränkter Haftung), Mannheim, Germany). The oligo sequences of the primers (sense and antisense) were designed with ProbeFinder software (Apelin, NM_017413.4, F, 5´ gaa agt ggg gga tgg cta ag 3´, R, 5´ ccc acc cac tac cct ctt ct 3´, Omentin, NM_017625.2, F, 5´ tga ggg tca ccg gat gta ac 3´, R, 5´ gga ctg gcc tct gga aag ta 3´, Resistin, NM_001193374.1, F, 5´ cca ccg aga ggg atg aaa g 3´, R, 5´ ttc ttc cat gga gca cag g 3´ and Visfatin, NM_005746.2, F, 5´ aag gga tgg aac tac att ctt gag 3´, R, 5´ ctg tgt ttt cca ccg tga ag 3'. The reaction mix was prepared according to the manufacturer's protocol. Each sample was analyzed in duplicate, and the data obtained were analyzed with the LightCycler nano software.

Statistical analysis The distribution of the quantitative data was performed by Shapiro Wilk. The comparison of frequencies was carried out with X2, while the comparison of basal means between groups was performed with Student's t-test. Final means were compared with Student's t-test when no statistical differences were found in basal comparison, while in the parameters with significant differences in the basal measurement, a covariate adjustment (repeated measures ANOVA) and the Bonferroni test were applied to compare the final means between groups. Self-controlled analysis was performed with paired t test. Analyses were performed with GraphPad Prism software, version 8.0.0 for Windows (GraphPad Software, San Diego, CA, USA), and SPSS software, version 19 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 19.0. Armonk, NY(New York), USA: IBM Corp). A value of p<0.05 was considered as statistical significance.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose < 126 mg/dL or glycated hemoglobin < 6.5%)

Exclusion Criteria:

  • pregnant patients,
  • diabetics,
  • patients with allergic reaction to any components of the supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gymnema sylvestre
Patients who present Obesity administrated with Gymnema sylvestre. At a dose of two 200 mg capsules before breakfast
Dietary supplement: Gymnema sylvestre
Gymnema sylvestre also known as "meshashringi", is a plant from central and southern India. The leaf extract has been used as a laxative, diuretic, and cough suppressant; Likewise, it has antimicrobial, antihypercholesterolemic, and hepatoprotective activities. It is associated with antioxidant properties . Its adjuvant effect has been reported in the therapy of type 2 diabetes, revealing how its active compounds can influence glucose regulation and improve insulin sensitivity.
Experimental: Berberine
Patients who present Obesity administrated with Berberine 500 mg tablet three times a day before each meal
Dietary supplement: Berberine
Berberine is an alkaloid derived from plants native to China called Rhizoma coptidis, Cortex phellodendrine and Hydrastis canadensis. These plants are used in the treatment of infectious diarrhea, inflammation, DM2, non-alcoholic fatty liver disease, dyslipidemias, cardiovascular diseases, and obesity. They have been shown to improve insulin sensitivity and stimulate glucose uptake through the activation of AMP-activated protein kinase (AMPK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 3 months
Body weight
3 months
height
Time Frame: 3 months
height
3 months
waist
Time Frame: 3 months
waist long
3 months
hip circumference
Time Frame: 3 months
hip circumference
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 3 months
blood pressure
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Polytechnic Institute, Mexico

Collaborators

Instituto Nacional de Pediatria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 18, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESM.CE-01/7-12-2015
  • 20170253 (Other Identifier: Instituto Politécnico Nacional México)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Publication of the article in a JCR journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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