Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

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.

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Detailed Description

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Conditions

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HIV-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV-infected Individuals

Angiotensin II Infusion

Intervention Type DRUG

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.

non-HIV-infected Individuals

Angiotensin II Infusion

Intervention Type DRUG

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.

Interventions

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Angiotensin II Infusion

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Current or recent steroid use within last 2 months.
3. Known diabetes and/or use of antidiabetic medications
4. Creatinine \> 1.5 mg/dL
5. Potassium (K) \> 5.5 mEq/L
6. Hemoglobin (Hgb) \< 11.0 mg/dL
7. Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)
8. Thyroid disease/abnormal thyroid stimulating hormone (TSH)
9. Significant electrocardiographic abnormalities at screen such as heart block or ischemia
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (CAD)
11. For women: Pregnant or actively seeking pregnancy, or breastfeeding
12. Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing hormone (GHRH) or ketoconazole use within 3 months.
13. Current viral, bacterial or other infections (excluding HIV)
14. Current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes