Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Placebo
* Drug: Gymnema Sylvestre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.<br>* Other names: Calcined Magnesia;|
| Experimental: Gymnema Sylvestre<br>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<br>* 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.<br>* Other names: Gurmar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | week 12 | 
| Total Insulin Secretion | The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose). | Week 12 | 
| First Phase of Insulin Secretion | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gymnema Sylvestre, Insulin Secretion, Insulin Sensitivity, Central Obesity