Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 24-hour urine aldosterone to creatinine ratio
研究概览
简要总结
The purpose of this study is to see if individuals with HIV-infection, particularly those with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis. Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the body, and they may also have effects on sugar metabolism and cardiovascular health. There is some evidence that individuals with HIV-associated abdominal fat accumulation may have increased aldosterone, which may contribute to abnormalities in sugar metabolism and increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and without HIV infection, and with and without increased belly fat. The investigators hypothesize that aldosterone will be increased in HIV-infected individuals compared to those without HIV-infection, and that aldosterone will be further increased in HIV-infected individuals with increased abdominal fat compared to those without abdominal fat accumulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable use of antiretroviral therapy for at least 3 months (HIV group)
- •Age ≥ 18 and ≤ 65 years of age
排除标准
- •Antihypertensive use, including angiotensin converting enzyme inhibitors or angiotensin II receptor blocker use, diuretics, beta-blockers, calcium-channel blockers, potassium supplements, and spironolactone; and/or blood pressure (BP) >140/90 at screen
- •Current or recent steroid use within last 2 months.
- •Known diabetes and/or use of antidiabetic medications
- •Creatinine > 1.5 mg/dL
- •Potassium (K) > 5.5 mEq/L
- •Hemoglobin (Hgb) < 11.0 mg/dL
- •Alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN)
- •Thyroid disease/abnormal thyroid stimulating hormone (TSH)
- •Significant electrocardiographic abnormalities at screen such as heart block or ischemia
- •History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (CAD)
- •For women: Pregnant or actively seeking pregnancy, or breastfeeding
- •Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing hormone (GHRH) or ketoconazole use within 3 months.
- •Current viral, bacterial or other infections (excluding HIV)
- •Current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse
研究组 & 干预措施
HIV-infected Individuals
干预措施: Angiotensin II Infusion (Drug)
non-HIV-infected Individuals
干预措施: Angiotensin II Infusion (Drug)
结局指标
主要结局
24-hour urine aldosterone to creatinine ratio
时间窗: baseline
次要结局
- Intramyocellular Lipid(baseline)
- Flow mediated dilation(baseline)
- Hepatic fat(baseline)
- Plasma Renin Activity(baseline)
- Aldosterone response to Angiotensin II Infusion(baseline)
- Insulin stimulated glucose uptake(baseline)
研究者
Steven K. Grinspoon, MD
Principal Investigator
Massachusetts General Hospital