Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

June 8, 2019 updated by: Esperanza Martínez-Abundis, University of Guadalajara

Effect of Gymnema Sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Letter of consent and release signed by each patient
  • Body mass index: 25-34.99 kg/m2
  • Body weight without variations above or under 5% during the three months prior to the study
  • Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)

Plus any two of the following four factors:

  • Triglycerides: 150-499 mg/dL.
  • High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL.
  • Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
  • Fasting glucose: 100-125 mg/dL

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus
  • Previous pharmacological treatment for components of metabolic syndrome
  • Mental or physical illness interfering with the study
  • Thyroid or cardiovascular disease
  • Pregnant or suspected pregnant women
  • Woman breastfeeding
  • Index of body mass: ≥ 35 kg/m2
  • Treatments known to affect metabolism of glucose, fats and affecting arterial tension
  • Patients with hepatic or renal diseases background
  • Patients diagnosed with kidneys disease
  • Calcined magnesium intolerance
  • Gymnema Sylvestre intolerance

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Drug: Placebo
Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Other Names:
  • Calcined Magnesia
Experimental: Gymnema Sylvestre
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Drug: Gymnema Sylvestre
Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Other Names:
  • Gurmar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist Circumference (WC)
Time Frame: Week 12
The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Week 12
Triglycerides (TGs)
Time Frame: week 12
The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
week 12
High-density Lipoprotein Cholesterol (HDL-C)
Time Frame: Week 12
The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.
Week 12
Fasting Plasma Glucose (FPG)
Time Frame: week 12
The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
week 12
Systolic Blood Pressure (SBP)
Time Frame: week 12
The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
week 12
Diastolic Blood Pressure (DBP)
Time Frame: week 12
The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
week 12
Total Insulin Secretion
Time Frame: Week 12
The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).
Week 12
First Phase of Insulin Secretion
Time Frame: week 12
The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').
week 12
Insulin Sensitivity
Time Frame: week 12
The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight (BW)
Time Frame: week 12
The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
week 12
Body Mass Index (BMI)
Time Frame: week 12
The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
week 12
Total Cholesterol (TC)
Time Frame: week 12
The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
week 12
Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: Week 12
The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.
Week 12
Very-low Density Lipoprotein (VLDL)
Time Frame: week 12
The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.
week 12
2-hour Postload Plasma Glucose (2-h PG)
Time Frame: week 12
The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
week 12
Area Under the Curve of Glucose (AUCG)
Time Frame: week 12
The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.
week 12
Area Under the Curve of Insulin (AUCI)
Time Frame: week 12
The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.
week 12

Collaborators and Investigators

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

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: Esperanza Martínez, PhD, Institute of Experimental and Clinical Therapeutics

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

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

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 8, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-271281-YZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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