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NCT Number: NCT02370121

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Gymnema Sylvestre

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 24, 2015
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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