ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02370121
Recruitment Status : Completed
First Posted : February 24, 2015
Results First Posted : June 3, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Placebo Drug: Gymnema Sylvestre Phase 2

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Gymnema Sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

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 Name: 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 Name: Gurmar




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Total Insulin Secretion [ Time Frame: Week 12 ]
    The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

  8. 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').

  9. 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)].


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370121


Sponsors and Collaborators
University of Guadalajara
Investigators
Principal Investigator: Esperanza Martínez, PhD Institute of Experimental and Clinical Therapeutics

Publications of Results:

Other Publications:
Responsible Party: Esperanza Martínez-Abundis, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02370121     History of Changes
Other Study ID Numbers: CT-271281-YZ
First Posted: February 24, 2015    Key Record Dates
Results First Posted: June 3, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Gymnema Sylvestre
Insulin Secretion
Insulin Sensitivity
Central Obesity

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs