Metformin treatment for diabetes prevention in Africa
- Conditions
- Prediabetes in person who are on HIV treatmentNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN76157257
- Lead Sponsor
- iverpool School of Tropical Medicine
- Brief Summary
2023 Results article in https://doi.org/10.1007/s00125-023-05968-7 (added 18/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 364
1. HIV-positive on antiretroviral therapy (ART) for at least 6 months and considered stable on treatment (i.e. in regular attendance for care).
2. BMI>30 combined with either impaired fasting glucose (6.1 to 6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (7.0 to 11.10 mmol/L)
3. BMI<=30 combined with either impaired fasting glucose (6.3 to 6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (9.0 to 11.10 mmol/L)
4. Planning to remain in the area for > 6-months
5. Written informed consent
1. Pregnant women
2. Renal disease or renal dysfunction (eGFR<45)
3. Signs and symptoms of any form of acute metabolic acidosis including lactic acidosis and diabetic ketoacidosis
4. Other acute conditions with:
4.1 the potential to alter renal function including: dehydration, severe infection or shock
4.2 the potential to cause tissue hypoxia including decompensated heart failure, respiratory failure, recent myocardial infarction, shock
5. Congestive heart failure requiring pharmacological treatment
6. Clinical evidence of liver disease
7. Evidence of alcoholism or acute alcohol intoxication
8. Known hypersensitivity to metformin or any excipients associated with the preparation (in this case: Magnesium stearate, sodium carboxymethylcellulose, hypromellose)
9. Other acute conditions requiring hospital admission.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycaemia at 12 months as ascertained by the oral glucose tolerance test.
- Secondary Outcome Measures
Name Time Method <br> Current secondary outcome measures as of 20/05/2020:<br> 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test at 6 and 12 months<br> 2. Incidence of adverse events assessed using patient notes at 12 months<br> 3. Rates of retention in care assessed using patient notes at 12 months<br> 4. Estimated adherence to study drugs assessed using patient notes at 12 months<br><br> Previous secondary outcome measures:<br> 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test<br> 2. Incidence of adverse events assessed using patient notes at 12 months<br> 3. Rates of retention in care assessed using patient notes at 12 months<br> 4. Estimated adherence to study drugs assessed using patient notes at 12 months<br>