Phase 2
Completed N=24
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Source: ClinicalTrials.gov NCT02370121 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Waist Circumference (WC) — 101; 96 cm — p=0.57
Summary
Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waist Circumference (WC) |
101; 96 | 0.57 |
| PRIMARY Triglycerides (TGs) |
2.79; 1.70 | 0.07 |
| PRIMARY High-density Lipoprotein Cholesterol (HDL-C) |
1.03; 1.08 | 0.79 |
| PRIMARY Fasting Plasma Glucose (FPG) |
5.00; 4.83 | 0.08 |
| PRIMARY Systolic Blood Pressure (SBP) |
122; 121 | 0.95 |
| PRIMARY Diastolic Blood Pressure (DBP) |
83; 78 | 0.92 |
| PRIMARY Total Insulin Secretion |
0.95; 0.59 | 0.42 |
| PRIMARY First Phase of Insulin Secretion |
1805; 1366 | 0.77 |
| PRIMARY Insulin Sensitivity |
2.5; 4.1 | 0.17 |
| SECONDARY Body Weight (BW) |
80.3; 77.9 | 0.02 sig |
| SECONDARY Body Mass Index (BMI) |
30.70; 30.43 | 0.02 sig |
| SECONDARY Total Cholesterol (TC) |
5.04; 4.55 | 0.83 |
| SECONDARY Low-density Lipoprotein Cholesterol (LDL-C) |
2.77; 2.69 | 0.24 |
| SECONDARY Very-low Density Lipoprotein (VLDL) |
0.56; 0.35 | 0.05 |
| SECONDARY 2-hour Postload Plasma Glucose (2-h PG) |
6.83; 7.22 | 0.32 |
| SECONDARY Area Under the Curve of Glucose (AUCG) |
965; 914 | 0.17 |
| SECONDARY Area Under the Curve of Insulin (AUCI) |
90816; 60468 | 0.89 |
Eligibility Criteria
Inclusion Criteria
- Letter of consent and release signed by each patient
- Body mass index: 25-34.99 kg/m2
- Body weight without variations above or under 5% during the three months prior to the study
- Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)
Plus any two of the following four factors:
- Triglycerides: 150-499 mg/dL.
- High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL.
- Blood pressure systolic: 130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
- Fasting glucose: 100-125 mg/dL
Exclusion Criteria
- Type 1 or 2 diabetes mellitus
- Previous pharmacological treatment for components of metabolic syndrome
- Mental or physical illness interfering with the study
- Thyroid or cardiovascular disease
- Pregnant or suspected pregnant women
- Woman breastfeeding
- Index of body mass: ≥ 35 kg/m2
- Treatments known to affect metabolism of glucose, fats and affecting arterial tension
- Patients with hepatic or renal diseases background
- Patients diagnosed with kidneys disease
- Calcined magnesium intolerance
- Gymnema Sylvestre intolerance
Data sourced from ClinicalTrials.gov (NCT02370121). 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. Informational only — not medical advice.