Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2014 by Massachusetts General Hospital

Sponsor:

Information provided by (Responsible Party):

Steven K. Grinspoon, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01407237

First received: July 27, 2011

Last updated: August 1, 2014

Last verified: August 2014

History of Changes

Purpose

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.

Condition	Intervention
HIV-infection	Drug: Angiotensin II Infusion


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Aldosterone

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

24-hour urine aldosterone to creatinine ratio [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma Renin Activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
Aldosterone response to Angiotensin II Infusion [ Time Frame: baseline ] [ Designated as safety issue: No ]
Flow mediated dilation [ Time Frame: baseline ] [ Designated as safety issue: No ]
Intramyocellular Lipid [ Time Frame: baseline ] [ Designated as safety issue: No ]
Hepatic fat [ Time Frame: baseline ] [ Designated as safety issue: No ]
Insulin stimulated glucose uptake [ Time Frame: baseline ] [ Designated as safety issue: No ]


Estimated Enrollment:	100
Study Start Date:	January 2012
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407237

Contacts


Contact: Suman Srinivasa, MD	617-726-1585	ssrinivasa@partners.org
Contact: Katie Fitch, NP	617-724-8015	kfitch@partners.org

Locations


United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven K Grinspoon, MD 617-724-9109 sgrinspoon@partners.org

Sponsors and Collaborators

Massachusetts General Hospital

More Information

No publications provided


Responsible Party:	Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01407237 History of Changes
Other Study ID Numbers:	2011P000250
Study First Received:	July 27, 2011
Last Updated:	August 1, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:


HIV-infection renin aldosterone visceral fat

Additional relevant MeSH terms:


Angiotensin II Cardiovascular Agents Pharmacologic Actions Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 03, 2015

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