Phase 2
N=30
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Impaired Glucose Tolerance
Bottom Line
View on ClinicalTrials.gov: NCT02708966 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Fasting Plasma Glucose — 77.4; 77.7 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gymnema Sylvestre (Drug); Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Plasma Glucose |
77.4; 77.7 | — |
| PRIMARY 2-hour Post Load Plasma Glucose (2-h PG) |
7.8; 7.9 | — |
| PRIMARY Glycated Hemoglobin A1c (A1C) |
5.4; 5.7 | — |
| PRIMARY Total Insulin Secretion (Insulinogenic Index) |
0.51; 0.49 | — |
| PRIMARY First Phase of Insulin Secretion |
1399; 1528 | — |
| PRIMARY Insulin Sensitivity (Matsuda Index) |
2.4; 2.5 | — |
| SECONDARY Area Under the Curve of Glucose |
1075; 1018 | — |
| SECONDARY Area Under the Curve of Insulin |
56968; 53374 | — |
| SECONDARY Body Weight (BW) |
77.4; 77.7 | — |
| SECONDARY Body Mass Index (BMI) |
30.3; 29.3 | — |
| SECONDARY Waist Circumference (WC) |
97.3; 99 | — |
| SECONDARY Systolic Blood Pressure (SBP) |
120; 120 | — |
| SECONDARY Diastolic Blood Pressure (DBP) |
75; 77 | — |
| SECONDARY Total Cholesterol |
4.7; 5.4 | — |
| SECONDARY Triglycerides |
1.7; 1.6 | — |
| SECONDARY High Density Lipoprotein Cholesterol |
0.9; 1.0 | — |
| SECONDARY Low Density Lipoprotein |
2.5; 3.2 | — |
| SECONDARY Very Low Density Lipoprotein |
0.3; 0.3 | — |
| SECONDARY Creatinine |
70.8; 70.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02708966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.