- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02708966
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
January 14, 2021 updated by: Esperanza Martínez-Abundis, University of Guadalajara
Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44340
- Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gymnema Sylvestre
Patients with IGT
|
Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Other Names:
|
Placebo Comparator: Placebo
Patients with IGT
|
Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Plasma Glucose
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
2-hour Post Load Plasma Glucose (2-h PG)
Time Frame: 90 days
|
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)
Time Frame: 90 days
|
After intervention by high-performance liquid chromatography
|
90 days
|
Total Insulin Secretion (Insulinogenic Index)
Time Frame: 90 days
|
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
|
90 days
|
First Phase of Insulin Secretion
Time Frame: 90 days
|
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)
Time Frame: 90 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve of Glucose
Time Frame: 90 days
|
Area under the curve of glucose was obtained using the trapezoidal integration.
|
90 days
|
Area Under the Curve of Insulin
Time Frame: 90 days
|
After intervention area under the curve of insulin
|
90 days
|
Body Weight (BW)
Time Frame: 12 weeks
|
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
|
Body Mass Index (BMI)
Time Frame: 12 weeks
|
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
|
Waist Circumference (WC)
Time Frame: 12 weeks
|
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
|
Systolic Blood Pressure (SBP)
Time Frame: 12 weeks
|
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
|
Diastolic Blood Pressure (DBP)
Time Frame: 12 weeks
|
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
|
Total Cholesterol
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
Triglycerides
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
High Density Lipoprotein Cholesterol
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
Low Density Lipoprotein
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
Very Low Density Lipoprotein
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
Creatinine
Time Frame: 90 days
|
After intervention by spectrophotometry
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esperanza Martínez-Abundis, PhD, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
March 10, 2016
First Submitted That Met QC Criteria
March 10, 2016
First Posted (Estimate)
March 15, 2016
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GSIG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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