Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Completed

Conditions studied: HIV-infection

In brief

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.

Key facts

Study ID

NCT01407237

Run by

Massachusetts General Hospital

People needed

30

Starts

2012-01-01

Last updated by the study team

2016-08-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Stable use of antiretroviral therapy for at least 3 months (HIV group)
• Age ≥ 18 and ≤ 65 years of age

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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