Reversing the Biological Clock: Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Second generation epigenetic aging clock
研究概览
简要总结
This study is a pilot, open-lable, two-arm study. The investigators will enroll virally suppressed people living with HIV and obesity to evaluate the effect of tirzepatide on epigenetic aging, assessed by DNA methylation-based clocks using peripheral blood. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •- Adult people living with HIV, who are virally suppressed, defined as plasma HIV viral load is < 200 copies/mL within 6 months before enrollment. Participants have to have BMI > 30 kg/m2.
排除标准
- •Participants cannot have undergone treatment with any incretin-based treatment within the past 90 days before enrollment. Participants cannot have any AIDS-defining illnesses, active malignancy, or history of decompensated liver failure. Participants cannot be pregnant. Participants cannot have history of acute pancreatitis or a family history of medullary thyroid cancer.
研究组 & 干预措施
Standard of care
Participants enrolled in the standard of care arm will undergo identical imaging and blood testing, but without bictegravir PK/PD. They will receive diet and nutrition consult delivered via a smartphone-based application throughout the study course.
Interventional
Participants enrolled in the interventional arm will undergo baseline imaging and blood testing, followed by an 8-week diet and nutrition consultation delivered via a smartphone-based application. Participants will then receive tirzepatide treatment for 25 weeks, after which imaging and blood testing will be repeated. Tirzepatide will subsequently be withheld for 24 weeks, with imaging and blood testing repeated once more to assess the persistence of treatment effect. Bictegravir PK/PD study will be done to assess whether tirzepatide will affect bictegravir pharmacokinetics during the study.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Second generation epigenetic aging clock
时间窗: Baseline, week 33, week 57
PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years.
Third generation epigenetic aging clock
时间窗: Baseline, week 33, week 57
DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year.
次要结局
- Intrahepatic triglycerides(Baseline, week 33, week 57)
- Change in body composition assessed by dual-energy X-ray absorptiometry (DXA)(Baseline, week 33, week 57)
- Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA)(Baseline, week 33, week 57)
- Patient reported outcome(Baseline, week 33, week 57)
- Drinking habits(Baseline, week 33, week 57)
- Body weight(Baseline, week 8, week 13, week 21, week 33, week 57)
- Waist circumference(Baseline, week 8, week 13, week 21, week 33, week 57)
- Inflammation markers(Baseline, week 33, week 57)
- Total bilirubin(Baseline, week 33, week 57)
- Alanine transaminase(Baseline, week 33, week 57)
- Aspartate transminase(Baseline, week 33, week 57)
- Fibrosis-4 index(Baseline, week 33, week 57)
- A1c(Baseline, week 33, week 57)
- Fasting plasma glucose(Baseline, week 33, week 57)
- Fasting serum insulin(Baseline, week 33, week 57)
- Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Baseline, week 33, week 57)
- Lipid profile(Baseline, week 33, week 57)
- Creatinine(Baseline, week 33, week 57)
- NT-proBNP(Baseline, week 33, week 57)
- Blood pressure(Baseline, week 8, week 13, week 21, week 33, week 57)
研究者
National Taiwan University Clinical Trial Center
Professor Hisn-Yun Sun
National Taiwan University Hospital