Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

Study Overview
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Brief Summary
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Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.

Detailed Description
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The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p <0.05.

Official Title
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Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.

Conditions
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Impaired Glucose Tolerance

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 25.0-34.99 kg / m2. Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.) Written informed consent. body weight stable over the last 3 months. Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests. Women who are not contemplated get pregnant within the next 6 months. Exclusion Criteria: Women pregnant or breastfeeding. Physical or mental disability that makes it impossible to perform the intervention. Diagnosis of hypertension or heart failure. Smokers. Untreated thyroid disease. Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering). Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes. Diagnosis of renal disease or creatinine > 1.5 mg / dl. Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%. Total Cholesterol ≥ 280 mg/dL. Triglycerides ≥ 300 mg/dL. Known allergy to calcined magnesia or Gymnema sylvestre.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gymnema Sylvestre<br>Patients with IGT | Drug: Gymnema Sylvestre<br>* Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner<br>* Other names: Gurmar;|
| Placebo Comparator: Placebo<br>Patients with IGT | Drug: Placebo<br>* Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner<br>* Other names: Calcined Magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose | After intervention by spectrophotometry | 90 days | 
| 2-hour Post Load 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. | 90 days | 
| Glycated Hemoglobin A1c (A1C) | After intervention by high-performance liquid chromatography | 90 days | 
| Total Insulin Secretion (Insulinogenic Index) | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention. | 90 days | 
| First Phase of Insulin Secretion | 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') after intervention. | 90 days | 
| Insulin Sensitivity (Matsuda Index) | 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)] after intervention. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of Glucose | Area under the curve of glucose was obtained using the trapezoidal integration. | 90 days | 
| Area Under the Curve of Insulin | After intervention area under the curve of insulin | 90 days | 
| Body Weight (BW) | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | 12 weeks | 
| Body Mass Index (BMI) | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | 12 weeks | 
| Waist Circumference (WC) | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12 | 12 weeks | 
| Systolic Blood Pressure (SBP) | The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | 12 weeks | 
| Diastolic Blood Pressure (DBP) | The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | 12 weeks | 
| Total Cholesterol | After intervention by spectrophotometry | 90 days | 
| Triglycerides | After intervention by spectrophotometry | 90 days | 
| High Density Lipoprotein Cholesterol | After intervention by spectrophotometry | 90 days | 
| Low Density Lipoprotein | After intervention by spectrophotometry | 90 days | 
| Very Low Density Lipoprotein | After intervention by spectrophotometry | 90 days | 
| Creatinine | After intervention by spectrophotometry | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gymnema Sylvestre, Glycemic control