Back to resultsEffect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Gymnema Sylvestre
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Gymnema Sylvestre, Glycemic control
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.
Sites / Locations
- Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gymnema Sylvestre
Placebo
Arm Description
Patients with IGT
Patients with IGT
Outcomes
Primary Outcome Measures
Fasting Plasma Glucose
After intervention by spectrophotometry
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.
Glycated Hemoglobin A1c (A1C)
After intervention by high-performance liquid chromatography
Total Insulin Secretion (Insulinogenic Index)
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
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.
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.
Secondary Outcome Measures
Area Under the Curve of Glucose
Area under the curve of glucose was obtained using the trapezoidal integration.
Area Under the Curve of Insulin
After intervention area under the curve of insulin
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
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
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
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
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
Total Cholesterol
After intervention by spectrophotometry
Triglycerides
After intervention by spectrophotometry
High Density Lipoprotein Cholesterol
After intervention by spectrophotometry
Low Density Lipoprotein
After intervention by spectrophotometry
Very Low Density Lipoprotein
After intervention by spectrophotometry
Creatinine
After intervention by spectrophotometry
Full Information
NCT ID
NCT02708966
First Posted
March 10, 2016
Last Updated
January 14, 2021
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT02708966
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Gymnema Sylvestre, Glycemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gymnema Sylvestre
Arm Type
Experimental
Arm Description
Patients with IGT
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with IGT
Intervention Type
Drug
Intervention Name(s)
Gymnema Sylvestre
Other Intervention Name(s)
Gurmar
Intervention Description
Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined Magnesia
Intervention Description
Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Primary Outcome Measure Information:
Title
Fasting Plasma Glucose
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
2-hour Post Load Plasma Glucose (2-h PG)
Description
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.
Time Frame
90 days
Title
Glycated Hemoglobin A1c (A1C)
Description
After intervention by high-performance liquid chromatography
Time Frame
90 days
Title
Total Insulin Secretion (Insulinogenic Index)
Description
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
Time Frame
90 days
Title
First Phase of Insulin Secretion
Description
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.
Time Frame
90 days
Title
Insulin Sensitivity (Matsuda Index)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Area Under the Curve of Glucose
Description
Area under the curve of glucose was obtained using the trapezoidal integration.
Time Frame
90 days
Title
Area Under the Curve of Insulin
Description
After intervention area under the curve of insulin
Time Frame
90 days
Title
Body Weight (BW)
Description
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
Time Frame
12 weeks
Title
Body Mass Index (BMI)
Description
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
Time Frame
12 weeks
Title
Waist Circumference (WC)
Description
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
Time Frame
12 weeks
Title
Systolic Blood Pressure (SBP)
Description
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
Time Frame
12 weeks
Title
Diastolic Blood Pressure (DBP)
Description
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
Time Frame
12 weeks
Title
Total Cholesterol
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
Triglycerides
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
High Density Lipoprotein Cholesterol
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
Low Density Lipoprotein
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
Very Low Density Lipoprotein
Description
After intervention by spectrophotometry
Time Frame
90 days
Title
Creatinine
Description
After intervention by spectrophotometry
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez-Abundis, PhD
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
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Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
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