ISRCTN77382043进行中（未招募）3 期
Preventing and delaying the development of diabetes in Africa: a randomised placebo-controlled double-blind phase III trial of metformin in people living with HIV-infection and pre-diabetes.
niversity College London0 个研究点目标入组 2,100 人开始时间: 2020年7月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 12/12/2022:
- •1. Adult HIV-positive persons on antiretroviral therapy (ART) for at least 6 months and considered stable on treatment (i.e. in regular attendance for care). Considered by the clinical team to be in routine care with a plasma viral load of less than 1000 copies per ml taken within the last 12 months.
- •2. Either impaired fasting glucose (=6.1 to =6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (=7.8 to <11.10 mmol/L)
- •3. Planning to remain in the area for > 12 months
- •4. Written informed consent
- •Previous participant inclusion criteria:
- •1. HIV-positive and stable on the same antiretroviral therapy for at least 6-months
- •2. Attending the HIV clinic regularly for at least 6 months
- •3. Impaired fasting glucose of between 6.1 to 6.9 mmol/L and/or impaired glucose tolerance at 2 hours of 7.8 to 11.10 mmol/L
- •4. Planning to remain in the area for > 1 year
- •5. Willing to provide written informed consent
排除标准
- •Current participant exclusion criteria as of 12/12/2022:
- •1. Pregnant women
- •2. Patients who were participants of the META Phase II study
- •3. Renal disease or renal dysfunction (eGFR<45)
- •4. Signs and symptoms of any form of acute metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- •5. Other acute conditions with:
- •5.1. The potential to alter renal function including dehydration, severe infection or shock
- •5.2. The potential to cause tissue hypoxia including decompensated heart failure, respiratory failure, recent myocardial infarction, shock
- •6. Congestive heart failure requiring pharmacological treatment
- •7. Clinical evidence of liver disease
- •8. Evidence of alcoholism or acute alcohol intoxication
- •9. Known hypersensitivity to metformin or any excipients associated with the preparation (in this case: Magnesium stearate, sodium carboxymethylcellulose, hypromellose)
- •10. Other acute conditions requiring hospital admission or emergency clinical intervention, including blood pressure >180/110 mmHg, haemoglobin<6.5g/dL for women or haemoglobin <7.0g/dL for men (grade 3); white cell count <1.5 x 109 cells/mm3(grade 3) and any baseline liver function derangements at grade 4 according to DAIDS criteria.
- •Previous participant exclusion criteria:
- •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
研究者
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