Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Completed

• Conditions: HIV-infection
• Interventions: Drug: Angiotensin II Infusion

• Registration Number: NCT01407237
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Start: 2012-01
• Primary Completion: 2015-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-infected Individuals	Angiotensin II Infusion	-
non-HIV-infected Individuals	Angiotensin II Infusion	-

Primary Outcome Measures

Name	Time	Method
24-hour urine aldosterone to creatinine ratio	baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States