Obesity is a chronic disease of global public health concern, contributing to cardiovascular disease, type 2 diabetes and certain cancers. Currently approved anti-obesity drugs and surgery are expensive and not readily available in Nigeria. Metformin, approved for type 2 diabetes, has been shown to promote weight loss among obese patients in high income countries. However, metformin's effects have not yet been demonstrated in Black African populations, which may have different genetic and environmental predispositions to obesity and to the effect of metformin. This blinded, placebo-controlled, randomized trial is determining the effect of metformin on weight loss, cardiovascular disease risk and insulin resistance in Black Nigerians.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
Pathology Facility
Enugu, Enugu State, Nigeria
RECRUITINGUniversity of Nigeria Teaching Hospital
Enugu, Enugu State, Nigeria
RECRUITINGEffect of Metformin on body weight change
Determine percent change in body weight in kilograms and height in meters which will be combined to report BMI in kg/m2 among the treatment arm and compared to the control arm.
Time frame: 24 months
Effect of Metformin on Cardiovascular risk
Determine percent change in the 10 year Framingham risk score for cardiovascular disease among the treatment arm and compare with the control arm.
Time frame: 24 months
Effect of Metformin on insulin resistance in non-diabetics
Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm.
Time frame: 24 months
Effect of metformin on waist circumference change
Determine the percent change in waist circumference measured in cm at baseline and final readings among the treatment arm and compared to the control arm.
Time frame: 24 months
Effect of metformin on waist-to-hip circumference change
Determine the percent change in waist circumference measured in cm, and hip circumference measured in cm, which will be combined to report waist-to-hip circumference ratio change among the treatment arm and compared to the control arm.
Time frame: 24 months
Safety of Metformin extended release tablet taken daily
Determine the incidence of adverse effects at grade 3 or higher level using the Adverse Effect questionnaire when dosage of less than or equal to 1500mg of Metformin X extended release tablet is taken daily.
Time frame: 24 months
Percent drug compliance to Metformin extended release taken once daily.
Determine the percent drug compliance to administered Metformin extended release tablets, determined by count of actual number of drug tablets administered over count of what was expected to have been administered, expressed as a percentage.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.