HIV-infectionNCT01407237
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
An observational study of HIV-infection, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-infection
- What is being tested?
- Angiotensin II Infusion
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 HIV-infected and 50 non-HIV-infected male and female volunteers, ages 18-65 years old.
Who may be able to join
- Stable use of antiretroviral therapy for at least 3 months (HIV group)
- Age ≥ 18 and ≤ 65 years of age
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- HIV-infection
- Being tested
- Angiotensin II Infusion
- Keywords
- HIV-infection, renin, aldosterone, visceral fat
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II InfusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected Individuals | Not described Receives: Drug: Angiotensin II Infusion | |
| non-HIV-infected Individuals | Not described Receives: Drug: Angiotensin II Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine aldosterone to creatinine ratio
Measured: baseline
Secondary outcomes (6)
Plasma Renin Activity
Measured: baseline
Aldosterone response to Angiotensin II Infusion
Measured: baseline
Flow mediated dilation
Measured: baseline
Intramyocellular Lipid
Measured: baseline
Hepatic fat
Measured: baseline
Insulin stimulated glucose uptake
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-infectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407237
- Sponsor's protocol ID
- 2011P000250
- Status last verified
- Aug 2016
- First submitted
- 27 Jul 2011
- Last updated
- 5 Aug 2016
- Results posted
- No
Publications
Bogorodskaya M, Fitch KV, Burdo TH, Maehler P, Easly RM, Murray GR, Feldpausch M, Adler GK, Grinspoon SK, Srinivasa S. Serum Lipocalin 2 (Neutrophil Gelatinase-Associated Lipocalin) in Relation to Biomarkers of Inflammation and Cardiac Stretch During Activation of the Renin-Angiotensin-Aldosterone System in Human Immunodeficiency Virus. J Infect Dis. 2019 Sep 26;220(9):1420-1424. doi: 10.1093/infdis/jiz346.
PubMed 31298286Murphy CA, Fitch KV, Feldpausch M, Maehler P, Wong K, Torriani M, Adler GK, Grinspoon SK, Srinivasa S. Excessive Adiposity and Metabolic Dysfunction Relate to Reduced Natriuretic Peptide During RAAS Activation in HIV. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1558-1565. doi: 10.1210/jc.2017-02198.
PubMed 29408981O'Malley TK, Burdo TH, Robinson JA, Fitch KV, Grinspoon SK, Srinivasa S. Acute hyperinsulinemia effects on systemic markers of immune activation in HIV. AIDS. 2017 Jul 31;31(12):1771-1773. doi: 10.1097/QAD.0000000000001545.
PubMed 28514281Srinivasa S, Burdo TH, Williams KC, Mitten EK, Wong K, Fitch KV, Stanley T, Adler GK, Grinspoon SK. Effects of Sodium Restriction on Activation of the Renin-Angiotensin-Aldosterone System and Immune Indices During HIV Infection. J Infect Dis. 2016 Nov 1;214(9):1336-1340. doi: 10.1093/infdis/jiw392. Epub 2016 Aug 22.
PubMed 27549584Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18.
PubMed 26086328
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
- ClinicalTrials.gov ID
- NCT01407237
- Acronym / sponsor ID
- 2011P000250
- Conditions
- HIV-infection
- Keywords
- HIV-infection, renin, aldosterone, visceral fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected Individuals | – | Drug: Angiotensin II Infusion |
| non-HIV-infected Individuals | – | Drug: Angiotensin II Infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 HIV-infected and 50 non-HIV-infected male and female volunteers, ages 18-65 years old.
Key inclusion criteria (2 listed)
- Stable use of antiretroviral therapy for at least 3 months (HIV group)
- Age ≥ 18 and ≤ 65 years of age
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II InfusionAngiotensin 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. | Drug | HIV-infected Individuals, non-HIV-infected Individuals |
Primary outcome
24-hour urine aldosterone to creatinine ratio
Time frame: baseline
6 secondary outcomes
Plasma Renin Activity
Time frame: baseline
Aldosterone response to Angiotensin II Infusion
Time frame: baseline
Flow mediated dilation
Time frame: baseline
Intramyocellular Lipid
Time frame: baseline
Hepatic fat
Time frame: baseline
Insulin stimulated glucose uptake
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 31298286Bogorodskaya M, Fitch KV, Burdo TH, Maehler P, Easly RM, Murray GR, Feldpausch M, Adler GK, Grinspoon SK, Srinivasa S. Serum Lipocalin 2 (Neutrophil Gelatinase-Associated Lipocalin) in Relation to Biomarkers of Inflammation and Cardiac Stretch During Activation of the Renin-Angiotensin-Aldosterone System in Human Immunodeficiency Virus. J Infect Dis. 2019 Sep 26;220(9):1420-1424. doi: 10.1093/infdis/jiz346.
- Derived from this study: PubMed 29408981Murphy CA, Fitch KV, Feldpausch M, Maehler P, Wong K, Torriani M, Adler GK, Grinspoon SK, Srinivasa S. Excessive Adiposity and Metabolic Dysfunction Relate to Reduced Natriuretic Peptide During RAAS Activation in HIV. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1558-1565. doi: 10.1210/jc.2017-02198.
- Derived from this study: PubMed 28514281O'Malley TK, Burdo TH, Robinson JA, Fitch KV, Grinspoon SK, Srinivasa S. Acute hyperinsulinemia effects on systemic markers of immune activation in HIV. AIDS. 2017 Jul 31;31(12):1771-1773. doi: 10.1097/QAD.0000000000001545.
- Derived from this study: PubMed 27549584Srinivasa S, Burdo TH, Williams KC, Mitten EK, Wong K, Fitch KV, Stanley T, Adler GK, Grinspoon SK. Effects of Sodium Restriction on Activation of the Renin-Angiotensin-Aldosterone System and Immune Indices During HIV Infection. J Infect Dis. 2016 Nov 1;214(9):1336-1340. doi: 10.1093/infdis/jiw392. Epub 2016 Aug 22.
- Derived from this study: PubMed 26086328Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-infection, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine aldosterone to creatinine ratio (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407237, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.