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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

July 27, 2011
August 1, 2014
January 2012
July 2016   (final data collection date for primary outcome measure)
24-hour urine aldosterone to creatinine ratio [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01407237 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

HIV-infection
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.
  • HIV-infected Individuals
    Intervention: Drug: Angiotensin II Infusion
  • non-HIV-infected Individuals
    Intervention: Drug: Angiotensin II Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Suman Srinivasa, MD 617-726-1585 ssrinivasa@partners.org
Contact: Katie Fitch, NP 617-724-8015 kfitch@partners.org
United States
 
NCT01407237
2011P000250
Not Provided
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP