Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01407237
First received: July 27, 2011
Last updated: May 1, 2013
Last verified: May 2013
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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:
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 |
| 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
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: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
HIV-infection renin aldosterone visceral fat |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Angiotensin II Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013