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

Study Overview
=================
Brief Summary
-----------------
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.

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 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.

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

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Drug: Banaba
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Banaba<br>Banaba capsules, 500mg, two times per day before meals during 90 days | Drug: Banaba<br>* Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.<br>* Other names: Lagerstroemia speciosa;|
| Placebo Comparator: Placebo<br>Calcined magnesia capsules, 500mg, two times per day before meals during 90 days | Drug: placebo<br>* Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg<br>* Other names: calcined magnesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride Levels at Week 12 | The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques. | 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. | 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 | 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 | 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. | 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. | Week 12 | 
| Total Insulin Sensitivity at Week 12 | Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12. | Week 12 | 
| Waist Circumference at Week 12 | Waist circumference will be evaluated at baseline and at week 12 with a flexible tape | Week 12 | 
| Diastolic Blood Pressure at Week 12 | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity