Insulin Resistance, Obesity and Cardiovascular Risk, Obesity (Body Mass Index >30 kg/m2)
Conditions
Keywords
Obesity, Metformin use, Weight loss, Non-diabetic
Brief summary
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.
Interventions
DRUGMetformin
Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily
DRUGPlacebo
Starch-based, identical looking placebo
Sponsors
Cures Within Reach
University Of Nigeria Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Blinded Pharmacist
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Metformin on Cardiovascular risk | 24 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 waist circumference change | 24 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 change | 24 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. |
| Effect of Metformin on body weight change | 24 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 insulin resistance in non-diabetics | 24 months | Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent drug compliance to Metformin extended release taken once daily. | 24 months | 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. |
| Safety of Metformin extended release tablet taken daily | 24 months | 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. |
Countries
Nigeria
Contacts
Primary ContactChiamaka C Onu, BSc
Outcome results
None listed