Clinical trial NCT02708966: Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Official title: Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Keywords: Gymnema Sylvestre
Glycemic control
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fasting Plasma Glucose
timeFrame: 90 days
measure: 2-hour Post Load Plasma Glucose (2-h PG)
timeFrame: 90 days
measure: Glycated Hemoglobin A1c (A1C)
timeFrame: 90 days
measure: Total Insulin Secretion (Insulinogenic Index)
timeFrame: 90 days
measure: First Phase of Insulin Secretion
timeFrame: 90 days
measure: Insulin Sensitivity (Matsuda Index)
timeFrame: 90 days
Secondary outcomes:
measure: Area Under the Curve of Glucose
timeFrame: 90 days
measure: Area Under the Curve of Insulin
timeFrame: 90 days
measure: Body Weight (BW)
timeFrame: 12 weeks
measure: Body Mass Index (BMI)
timeFrame: 12 weeks
measure: Waist Circumference (WC)
timeFrame: 12 weeks
measure: Systolic Blood Pressure (SBP)
timeFrame: 12 weeks
measure: Diastolic Blood Pressure (DBP)
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: 90 days
measure: Triglycerides
timeFrame: 90 days
measure: High Density Lipoprotein Cholesterol
timeFrame: 90 days
measure: Low Density Lipoprotein
timeFrame: 90 days
measure: Very Low Density Lipoprotein
timeFrame: 90 days
measure: Creatinine
timeFrame: 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
name: Esperanza Martínez-Abundis, PhD
role: PRINCIPAL_INVESTIGATOR
References: