Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Study Overview
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Brief Summary
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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.

Official Title
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Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Conditions
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HIV-infection

Intervention / Treatment
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* Drug: Angiotensin II Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable use of antiretroviral therapy for at least 3 months (HIV group) Age ≥ 18 and ≤ 65 years of age Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected Individuals<br> | Drug: Angiotensin II Infusion<br>* Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.<br>|
| non-HIV-infected Individuals<br> | Drug: Angiotensin II Infusion<br>* Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine aldosterone to creatinine ratio |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Renin Activity |  | baseline | 
| Aldosterone response to Angiotensin II Infusion |  | baseline | 
| Flow mediated dilation |  | baseline | 
| Intramyocellular Lipid |  | baseline | 
| Hepatic fat |  | baseline | 
| Insulin stimulated glucose uptake |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-infection, renin, aldosterone, visceral fat