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Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

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ClinicalTrials.gov Identifier: NCT02708966
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : November 18, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Drug: Gymnema Sylvestre Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
Study Start Date : March 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Gymnema Sylvestre
Patients with IGT
Drug: Gymnema Sylvestre
Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Other Name: Gurmar

Placebo Comparator: Placebo
Patients with IGT
Drug: Placebo
Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Other Name: Calcined Magnesia




Primary Outcome Measures :
  1. Fasting Plasma Glucose [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  2. 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.

  3. Glycated Hemoglobin A1c (A1C) [ Time Frame: 90 days ]
    After intervention by high-performance liquid chromatography

  4. Total Insulin Secretion (Insulinogenic Index) [ Time Frame: 90 days ]
    Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Area Under the Curve of Glucose [ Time Frame: 90 days ]
    Area under the curve of glucose was obtained using the trapezoidal integration.

  2. Area Under the Curve of Insulin [ Time Frame: 90 days ]
    After intervention area under the curve of insulin

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Total Cholesterol [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  9. Triglycerides [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  10. High Density Lipoprotein Cholesterol [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  11. Low Density Lipoprotein [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  12. Very Low Density Lipoprotein [ Time Frame: 90 days ]
    After intervention by spectrophotometry

  13. Creatinine [ Time Frame: 90 days ]
    After intervention by spectrophotometry



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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708966


Locations
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Mexico
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Esperanza Martínez-Abundis, PhD Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
  Study Documents (Full-Text)

Documents provided by Esperanza Martínez-Abundis, University of Guadalajara:
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Responsible Party: Esperanza Martínez-Abundis, PHD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02708966    
Other Study ID Numbers: GSIG
First Posted: March 15, 2016    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Gymnema Sylvestre
Glycemic control
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases