Clinical trial NCT02370121: Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Official title: Effect of Gymnema Sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: Gymnema Sylvestre
Insulin Secretion
Insulin Sensitivity
Central Obesity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

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

Primary outcomes:
measure: Waist Circumference (WC)
timeFrame: Week 12
measure: Triglycerides (TGs)
timeFrame: week 12
measure: High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Week 12
measure: Fasting Plasma Glucose (FPG)
timeFrame: week 12
measure: Systolic Blood Pressure (SBP)
timeFrame: week 12
measure: Diastolic Blood Pressure (DBP)
timeFrame: week 12
measure: Total Insulin Secretion
timeFrame: Week 12
measure: First Phase of Insulin Secretion
timeFrame: week 12
measure: Insulin Sensitivity
timeFrame: week 12
Secondary outcomes:
measure: Body Weight (BW)
timeFrame: week 12
measure: Body Mass Index (BMI)
timeFrame: week 12
measure: Total Cholesterol (TC)
timeFrame: week 12
measure: Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Week 12
measure: Very-low Density Lipoprotein (VLDL)
timeFrame: week 12
measure: 2-hour Postload Plasma Glucose (2-h PG)
timeFrame: week 12
measure: Area Under the Curve of Glucose (AUCG)
timeFrame: week 12
measure: Area Under the Curve of Insulin (AUCI)
timeFrame: week 12
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics
name: Esperanza Martínez, PhD
role: PRINCIPAL_INVESTIGATOR
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