Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

University of Guadalajara24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

PlaceboDRUG

Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

Gymnema SylvestreDRUG

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Waist Circumference (WC)

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.

Time frame: Week 12

Triglycerides (TGs)

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.

Time frame: week 12

High-density Lipoprotein Cholesterol (HDL-C)

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.

Time frame: Week 12

Fasting Plasma Glucose (FPG)

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.

Time frame: week 12

Systolic Blood Pressure (SBP)

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.

Time frame: week 12

Diastolic Blood Pressure (DBP)

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.

Time frame: week 12

Total Insulin Secretion

The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Body Weight (BW)

The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

Time frame: week 12

Body Mass Index (BMI)

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.

Time frame: week 12

Total Cholesterol (TC)

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.

Time frame: week 12

Low-density Lipoprotein Cholesterol (LDL-C)

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.

Time frame: Week 12

Very-low Density Lipoprotein (VLDL)

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.

Time frame: week 12

2-hour Postload Plasma Glucose (2-h PG)

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.

Time frame: week 12

Area Under the Curve of Glucose (AUCG)

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.

Time frame: week 12

Area Under the Curve of Insulin (AUCI)

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.

Time frame: week 12