WU 360: Assessing the Impact of Integrase Strand Transfer Inhibitors (INSTI) to Protease Inhibitor (PI) Switch on Insulin Sensitivity and Fat Metabolism (ADIPOSITY): a Sub-study of DEFINE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}
研究概览
简要总结
A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.
详细描述
Synopsis Full study title: Assessing the impact of integrase strand transfer inhibitors (INSTI) to protease inhibitor (PI) switch on insulin sensitivity and fat metabolism (ADIPOSITY): a sub-study of DEFINE
Endpoints and objectives:
The following endpoints will be determined 12 and 24 weeks after switch from an INSTI-based antiretroviral therapy (ART) regimen to a PI-based regimen:
Primary endpoint: Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).
Secondary endpoints: 1) Change in insulin sensitivity (SI) at 24 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT); 2) Change in insulin secretion during the fsOGTT assessed by using C-peptide deconvolution; 3) Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI); 4) Change in adipocyte size by the osmium tetroxide fixation technique; and 5) Change in expression of genes associated with adipose tissue development, lipogenesis, inflammation and endocrine function by RNA sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Must be enrolled in the DEFINE study TMC114FD2HTX4004
- •Must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.
排除标准
- •• Contraindication to magnetic resonance imaging as determined by institutional policy.
- •Current diagnosis of diabetes mellitus
研究组 & 干预措施
Immediate switch
Immediate switch
干预措施: Frequently sampled glucose tolerance testing (Procedure)
Immediate switch
Immediate switch
干预措施: abdominal subcutaneous adipose tissue biopsy (Procedure)
Immediate switch
Immediate switch
干预措施: MRI scan to assess intrahepatic triglyceride content (Procedure)
Delayed switch
Delayed switch
干预措施: Frequently sampled glucose tolerance testing (Procedure)
Delayed switch
Delayed switch
干预措施: abdominal subcutaneous adipose tissue biopsy (Procedure)
Delayed switch
Delayed switch
干预措施: MRI scan to assess intrahepatic triglyceride content (Procedure)
结局指标
主要结局
Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}
时间窗: 12 weeks
Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA_IR
次要结局
- Adipocyte size measured by osmium tetroxide fixation technique(24 weeks)
- Adipocyte gene expression correlated with adipose tissue development(24 weeks)
- Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}(24 weeks)
- Intrahepatic triglyceride (IHTG) content measure by magnetic resonance(24 weeks)
- Intrahepatic triglyceride (IHTG) content measure by magnetic resonance(12 weeks)
- Adipocyte size measured by osmium tetroxide fixation technique(12 weeks)
- Adipocyte gene expression correlated with adipose tissue development(12 weeks)