Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

August 3, 2016 updated by: Steven K. Grinspoon, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 HIV-infected and 50 non-HIV-infected male and female volunteers, ages 18-65 years old.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-infected Individuals
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.
non-HIV-infected Individuals
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (ESTIMATE)

August 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P000250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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