Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

HIV-infection Clinical Trial

Official title:

Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407237
• Other study ID #: 2011P000250
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: August 3, 2016
• Start date: January 2012

Study information

• Verified date: August 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour urine aldosterone to creatinine ratio		baseline	No
Secondary	Plasma Renin Activity		baseline	No
Secondary	Aldosterone response to Angiotensin II Infusion		baseline	No
Secondary	Flow mediated dilation		baseline	No
Secondary	Intramyocellular Lipid		baseline	No
Secondary	Hepatic fat		baseline	No
Secondary	Insulin stimulated glucose uptake		baseline	No