Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
- Conditions
- Impaired Glucose Tolerance
- Interventions
- Drug: Gymnema SylvestreDrug: Placebo
- Registration Number
- NCT02708966
- Lead Sponsor
- University of Guadalajara
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gymnema Sylvestre Gymnema Sylvestre Patients with IGT Placebo Placebo Patients with IGT
- Primary Outcome Measures
Name Time Method Fasting Plasma Glucose 90 days After intervention by spectrophotometry
2-hour Post Load Plasma Glucose (2-h PG) 90 days 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.
Glycated Hemoglobin A1c (A1C) 90 days After intervention by high-performance liquid chromatography
Insulin Sensitivity (Matsuda Index) 90 days 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.
Total Insulin Secretion (Insulinogenic Index) 90 days Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
First Phase of Insulin Secretion 90 days 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.
- Secondary Outcome Measures
Name Time Method Body Weight (BW) 12 weeks 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
High Density Lipoprotein Cholesterol 90 days After intervention by spectrophotometry
Low Density Lipoprotein 90 days After intervention by spectrophotometry
Area Under the Curve of Glucose 90 days Area under the curve of glucose was obtained using the trapezoidal integration.
Area Under the Curve of Insulin 90 days After intervention area under the curve of insulin
Body Mass Index (BMI) 12 weeks 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
Total Cholesterol 90 days After intervention by spectrophotometry
Triglycerides 90 days After intervention by spectrophotometry
Waist Circumference (WC) 12 weeks 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
Systolic Blood Pressure (SBP) 12 weeks 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
Diastolic Blood Pressure (DBP) 12 weeks 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
Very Low Density Lipoprotein 90 days After intervention by spectrophotometry
Creatinine 90 days After intervention by spectrophotometry
Trial Locations
- Locations (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico