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

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767869
• Other study ID #: BANABA-MS
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: December 2020
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Banaba
Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
• placebo
Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Locations

Country	Name	City	State
Mexico	Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride Levels at Week 12	The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.	Week 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 (?AUC insulin/?AUC glucose), the entered values reflect the total insulin secretion at week 12.	Week 12
Primary	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 / vglucose 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
Primary	Waist Circumference at Week 12	Waist circumference will be evaluated at baseline and at week 12 with a flexible tape	Week 12
Primary	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	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
Secondary	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
Secondary	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
Secondary	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