The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
研究概览
简要总结
This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role all these different factors may potentially have in weight gain recently reported in clinical cohorts.
详细描述
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of dolutegravir (DTG) compared to no DTG for 28 days in HIV seronegative healthy volunteers.
Participants will be randomised 1:1 to one of two arms:
Group 1:
- Dolutegravir 50 mg once daily for the first 28 days of the study.
- No treatment for the last 44 days of the study.
Group 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
- Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
- No treatment for the last 44 days of the study.
干预措施: Dolutegravir (Drug)
Arm 2
- No treatment for the first 28 days of the study.
- Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
干预措施: Dolutegravir (Drug)
结局指标
主要结局
Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
时间窗: Baseline, day 28 and 72 for both groups.
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
次要结局
- Effect of Dolutegravir on Adipocytokines.(Baseline, day 28 & 72 for both groups.)
- Effect of Dolutegravir on Pituitary Hormones(Baseline, day 28 and 72 for both groups.)
- Effect of Dolutegravir on Changes in Indirect Calorimetry(Baseline, day 28 and 72 for both groups.)
- Effect of Dolutegravir on Lipid Profile Including Lipid Fractions(Baseline, day 28 and 72 for both groups.)
- Changes in Food Intake by Food Preference Questionnaire(Baseline, day 28 and 72 for both groups.)
- Change in Sleep Parameters by Sleep Questionnaires(Baseline, day 28 and 72 for both groups.)