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Completed

NCT Number: NCT01407237

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.

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Key information

Conditions

HIV-infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin II Infusion

Drug

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.

Primary outcomes

  1. 24-hour urine aldosterone to creatinine ratio

    Time frame: baseline

Secondary outcomes

  1. Plasma Renin Activity

    Time frame: baseline

  2. Aldosterone response to Angiotensin II Infusion

    Time frame: baseline

  3. Flow mediated dilation

    Time frame: baseline

  4. Intramyocellular Lipid

    Time frame: baseline

  5. Hepatic fat

    Time frame: baseline

  6. Insulin stimulated glucose uptake

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
First posted
Aug 2, 2011
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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