Clinical trial

Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07297290

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 59 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Cardiovascular Risk, Insulin Resistance, Obesity (Body Mass Index >30 kg/m2)

Full registry criteria

Inclusion Criteria: * • Obesity (defined as body mass index ≥ 30kg/m2), * Fasting plasma glucose (\<7.0mmol/L) * No medical treatment for weight control in the previous 12 months * No participation in a current clinical trial Exclusion Criteria: * • Obesity (defined as body mass index ≥ 30kg/m2), * Fasting plasma glucose (\<7.0mmol/L) * No medical treatment for weight control in the previous 12 months * No participation in a current clinical trial

Treatments and study arms

Metformin

Drug

Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily

Placebo

Drug

Starch-based, identical looking placebo

Primary outcomes

Effect of Metformin on body weight change24 months

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.

Effect of Metformin on Cardiovascular risk24 months

Determine percent change in the 10 year Framingham risk score for cardiovascular disease among the treatment arm and compare with the control arm.

Effect of Metformin on insulin resistance in non-diabetics24 months

Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm.

Effect of metformin on waist circumference change24 months

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.

Effect of metformin on waist-to-hip circumference change24 months

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Pathology Facility🌐 Enugu, Enugu State, Nigeria

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Emeka F Nnakenyi, MDContact

Email · Call +2348139427709

University of Nigeria Teaching Hospital🌐 Enugu, Enugu State, Nigeria

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Obinna D Onodugo, MDContact

Email · Call +2348035899750