Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

University of Guadalajara24 enrolled

Overview

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load. 12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months. The remaining 12 patients received placebo with the same prescription. Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index). This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome X

Interventions

BanabaDRUG

Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.

placeboDRUG

Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients both sexes, * Age between 30 and 60 years, * Metabolic Syndrome according to the IDF criteria * Waist circumference * Man ≥90 cm * Woman ≥80 cm And two of the following criteria: * High density lipoprotein * Man ≤40 mg/dL * Woman ≤50 mg/dL * Fasting glucose ≥100 mg/dL * Triglycerides ≥150 mg/dL * Blood pressure ≥130/85 mmHg * Informed consent signed Exclusion Criteria: * Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Hypersensibility to resveratrol * Physical impossibility for taking pills * Known uncontrolled renal, hepatic, heart or thyroid diseased * Previous treatment for the metabolic syndrome components * Body Mass Index ≥39.9 kg/m2 * Fasting glucose ≥126 mg/dL * Triglycerides ≥500 mg/dL * Total cholesterol ≥240 mg/dL * Low density lipoprotein (c-LDL) ≥190 mg/dL * Blood Pressure ≥140/90 mmHg

Locations (1)

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Triglyceride Levels at Week 12

The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.

Time frame: Week 12

High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12

The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.

Time frame: Week 12

Fasting Glucose Levels at Week 12

The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

Time frame: Week 12

Systolic Blood Pressure at Week 12.

The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12

Time frame: Week 12

First Phase of Insulin Secretion at Week 12

Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. 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'), the entered values reflect the frst phase of insulin secretion at week 12.

Time frame: Week 12

Total Insulin Secretion at Week 12.

Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.

Time frame: Week 12

Total Insulin Sensitivity at Week 12

Data from ClinicalTrials.gov

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Secondary Outcomes

Weight at Week 12

The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12

Time frame: Week 12

Body Mass Index at Week 12

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

Time frame: Week 12

Total Cholesterol at Week 12

The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12

Time frame: Week 12

Low-density Lipoprotein-cholesterol (LDL-C) at Week 12

The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12

Time frame: Week 12