Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Phase 2

Completed

Conditions: Metabolic Syndrome

Interventions: Drug: Placebo
Drug: Gymnema Sylvestre

Registration Number: NCT02370121

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Gymnema Sylvestre	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.

Primary Outcome Measures

Name	Time	Method
Waist Circumference (WC)	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.
Triglycerides (TGs)	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.
High-density Lipoprotein Cholesterol (HDL-C)	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.
Fasting Plasma Glucose (FPG)	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.
Systolic Blood Pressure (SBP)	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.
Diastolic Blood Pressure (DBP)	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.
Total Insulin Secretion	Week 12	The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).
First Phase of Insulin Secretion	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').
Insulin Sensitivity	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

Name	Time	Method
Body Weight (BW)	week 12	The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
Body Mass Index (BMI)	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.
Total Cholesterol (TC)	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.
2-hour Postload Plasma Glucose (2-h PG)	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.
Area Under the Curve of Insulin (AUCI)	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.
Very-low Density Lipoprotein (VLDL)	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.
Low-density Lipoprotein Cholesterol (LDL-C)	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.
Area Under the Curve of Glucose (AUCG)	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.