Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

NCT02708966 | Completed Phase 2 Results

• 1 other identifier: GSIG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Keywords

Gymnema Sylvestre; Glycemic control

Outcome Measures

Primary Outcomes (6)

• Fasting Plasma Glucose

  After intervention by spectrophotometry

  90 days

• 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

• Glycated Hemoglobin A1c (A1C)

  After intervention by high-performance liquid chromatography

  90 days

• Total Insulin Secretion (Insulinogenic Index)

  Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.

  90 days

• 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

• Insulin Sensitivity (Matsuda Index)

  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.

  90 days

Secondary Outcomes (13)

• Area Under the Curve of Glucose

  90 days

• Area Under the Curve of Insulin

  90 days

• Body Weight (BW)

  12 weeks

• Body Mass Index (BMI)

  12 weeks

• Waist Circumference (WC)

  12 weeks

Study Arms (2)

Gymnema Sylvestre

EXPERIMENTAL

Patients with IGT

Drug: Gymnema Sylvestre

Placebo

PLACEBO COMPARATOR

Patients with IGT

Drug: Placebo

Interventions

Gymnema Sylvestre DRUG

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

Also known as: Gurmar

Gymnema Sylvestre

Placebo DRUG

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

Also known as: Calcined Magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Gurmarin protein, Gymnema sylvestre

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dra. Esperanza Martínez Abundis
• Organization: Institute of Experimental and Clinical Therapeutics

esperanzamartnezabundi@yahoo.com

+52-33-10-58-52-00

Study Officials

• Esperanza Martínez-Abundis, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 2, 2021
• Results First Posted: November 18, 2020

Record last verified: 2021-01

Locations

ME (1)