Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

University of Guadalajara

Status and phase: Completed; Phase 2

Conditions: Metabolic Syndrome

Treatments: Drug: Placebo; Drug: Gymnema Sylvestre

Study type: Interventional

Funder types: Other

Identifiers

NCT02370121

CT-271281-YZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

Treatment:

Drug: Placebo

Gymnema Sylvestre

Experimental group

Description:

600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

Treatment:

Drug: Gymnema Sylvestre