Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02708966
Study type	Interventional
Source	University of Guadalajara
Contact
Status	Completed
Phase	Phase 2
Start date	March 2016
Completion date	October 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT04088461` - Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine	Phase 4
Completed	`NCT02621060` - Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance	Phase 2
Completed	`NCT01488279` - Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy	N/A
Completed	`NCT01521312` - ACute and Chronic Effects of Saxagliptin	Phase 2
Completed	`NCT01559896` - Egg Protein Hydrolysate and Vascular Function	N/A
Completed	`NCT01030978` - Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program	N/A
Completed	`NCT00573781` - Dietary Modulation of Gene Expression and Metabolic Pathways in Glucose Metabolism	Phase 2
Terminated	`NCT00846521` - Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity	Phase 4
Completed	`NCT00241072` - Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance	Phase 4
Completed	`NCT00536250` - Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth	N/A
Completed	`NCT02254317` - Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance	N/A
Completed	`NCT03764423` - Health Effects of Salmon Fishmeal in Humans	N/A
Recruiting	`NCT05347030` - Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population	N/A
Active, not recruiting	`NCT04341571` - Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.	Phase 2
Completed	`NCT02700334` - Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes	Phase 4
Active, not recruiting	`NCT01933529` - ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)	Phase 2
Completed	`NCT02135172` - Breaks in Sedentary Time and Glucose Regulation in Women	N/A
Active, not recruiting	`NCT01841229` - Effect of Ginseng on Glycemic Control	N/A
Completed	`NCT02248272` - Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.