Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

NCT ID: NCT02708966

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-10-31

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.

Conditions

Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gymnema Sylvestre

Patients with IGT

Group Type: EXPERIMENTAL

Gymnema Sylvestre

Intervention Type: DRUG

Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner

Placebo

Patients with IGT

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner

Interventions

Gymnema Sylvestre

Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner

Intervention Type: DRUG

Placebo

Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner

Intervention Type: DRUG

Other Intervention Names

Gurmar; Calcined Magnesia

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Esperanza Martínez-Abundis

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esperanza Martínez-Abundis, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Locations

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

GSIG

Identifier Type: -

Identifier Source: org_study_id