Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708966
• Other study ID #: GSIG
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2021
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

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

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose	After intervention by spectrophotometry	90 days
Primary	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
Primary	Glycated Hemoglobin A1c (A1C)	After intervention by high-performance liquid chromatography	90 days
Primary	Total Insulin Secretion (Insulinogenic Index)	Total insulin secretion was calculated with the insulinogenic index (?ABC insulin / ?ABC glucose) after intervention.	90 days
Primary	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
Primary	Insulin Sensitivity (Matsuda Index)	Insulin sensitivity was calculated with Matsuda index [10,000 / vglucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] after intervention.	90 days
Secondary	Area Under the Curve of Glucose	Area under the curve of glucose was obtained using the trapezoidal integration.	90 days
Secondary	Area Under the Curve of Insulin	After intervention area under the curve of insulin	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total Cholesterol	After intervention by spectrophotometry	90 days
Secondary	Triglycerides	After intervention by spectrophotometry	90 days
Secondary	High Density Lipoprotein Cholesterol	After intervention by spectrophotometry	90 days
Secondary	Low Density Lipoprotein	After intervention by spectrophotometry	90 days
Secondary	Very Low Density Lipoprotein	After intervention by spectrophotometry	90 days
Secondary	Creatinine	After intervention by spectrophotometry	90 days