Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-59
SponsorUniversity Of Nigeria Teaching Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugMetformin 500mg extended release tablets taken to a maximum of 1500mg once daily
Placebo
DrugStarch-based, identical looking placebo
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Treatment armExperimental treatment 1 intervention
Group B: Control armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect 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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Of Nigeria Teaching Hospital
Lead sponsor
Cures Within Reach
Collaborator
Source ClinicalTrials.gov