DRKS00033785尚未招募1 期
Fasting Mimicking Diet in people living with the human immunodeficiency virus - INGENIOUS
Rheinische Friedrich-Wilhelms-Universität Bonn vertreten durch die Medizinische Fakultät der Universität Bonn vertreten durch den Dekan der Medizinischen Fakultät0 个研究点目标入组 45 人开始时间: 2024年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •HIV infection under therapy
- •- Ability to swallow plant foods
- •- Body mass index (BMI) = 20 kg/m2
- •- Haemoglobin > 9 g/dl -
- •Normal white blood cell count
- •- Creatinine < 1.5 mg/dl or calculated creatinine clearance =50
- •- Uric acid < 6 mg/dl
- •- Fasting glucose > 65 mg/dl
- •- Total bilirubin < 2 mg/dl or < ULN
- •- Written informed consent
- •- Willingness and ability to perform blood, stool and urine analyses - Ability to remain in daily contact (by phone or email) with study personnel to provide key clinical information, including daily body weight, blood pressure, health status and adverse events on each of the five days of the diet
排除标准
- •- Unintentional weight loss = 5% in the last 3-6 months
- •- Known HCV and/or HBV co-infection
- •- Existing or planned pregnancy (positive pregnancy test in women, e.g. ß-HCG test in urine/serum) or breastfeeding
- •- Diagnosis of type I or type II diabetes mellitus requiring medical treatment
- •- Fasting glucose > 200 mg/dl
- •- Impaired renal function (creatinine > 1.5mg/dl; GFR <50%)
- •- Impaired liver function (total bilirubin > 2 mg/dl or AST/ALT 2-fold
研究者
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