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| Name | Class |
|---|---|
| Cures Within Reach | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Metformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily |
|
| Control arm | Placebo Comparator | Identical-looking placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Percent drug compliance to Metformin extended release taken once daily. |
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Inclusion Criteria:
• Obesity (defined as body mass index ≥ 30kg/m2),
Exclusion Criteria:
• Obesity (defined as body mass index ≥ 30kg/m2),
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiamaka C Onu, BSc | Contact | +2347031800855 | mowri2025@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| IFEYINWA D NNAKENYI, MD | University Of Nigeria Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pathology Facility | Recruiting | Enugu | Enugu State | Nigeria |
Study protocol, statistical analysis plan, informed consent form, Non-identifiable patient measurements.
IPD will be made available after publishing of the research work likely from 1 Jan 2029 for 5 years (31 Dec 2033)
The research institution, the research funders, potential collaborators and funders.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Blinded Pharmacist
| Placebo | Drug | Starch-based, identical looking placebo |
|
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. |
| 24 months |
| University of Nigeria Teaching Hospital | Recruiting | Enugu | Enugu State | Nigeria |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |