HIV InfectionsNCT00264251
Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance
A study testing Weight loss through diet and exercise and Rosiglitazone insulin sensitizing agent in people with HIV Infections and Insulin Resistance, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are: 1. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Insulin Resistance, Obesity
- What is being tested?
- Weight loss through diet and exercise and Rosiglitazone insulin sensitizing agent
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2007
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-infected or uninfected.
- Body mass index (BMI) at least 25.
- Excess visceral adipose tissue. Excess VAT will be determined in HIV+ and HIV- groups of men by a waist hip ratio > 0.95 and a waist circumference >88.2 cm, and in women by a waist:hip >0.9 and waist circumference >75.3 cm.
- Insulin resistance (fasting serum insulin level >16 μU/ml).
Who cannot join
- Unable to tolerate magnetic resonance imaging (MRI)
- Clinical evidence of active liver disease or a significantly abnormal liver function test (ALT >2.5x the upper limit of normal).
- Severe hyperlipidemia (fasting plasma triglycerides >500 mg/dL or fasting total cholesterol >300mg/dL)
- Current coronary artery disease including angina
- Peripheral vascular disease
- Uncontrolled hypertension
- Participation in a regular exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: Effect of Diet, Exercise and Rosiglitazone on Regional Fat and Insulin Resistance in HIV-Infected and Uninfected Men and Women
The purpose of this study is to determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are:
- Diet + exercise program.
- Rosiglitazone treatment.
- A combination treatment of diet + exercise program and rosiglitazone.
Read the detailed description
A constellation of nutritional alterations in HIV-infected patients receiving highly active antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and insulin resistance (IR) has been described. There is a major concern that these developments will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there are well documented associations among body fat distribution, insulin resistance, and adverse health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it is unclear if the relationships are affected by HIV infection, or if they reflect the same outcomes. This information is important, since understanding the interrelationships between body fat distribution and metabolism may guide the development of treatment strategies.
The specific hypotheses to be tested are:
- HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this therapy on insulin resistance.
- HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.
- The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a greater extent than rosiglitazone alone, and will improve insulin resistance to greater extent than diet and exercise alone, however these effects will be blunted in HIV-infected subjects.
- Conditions
- HIV Infections, Insulin Resistance, Obesity
- Being tested
- Weight loss through diet and exercise, Rosiglitazone insulin sensitizing agent
- Keywords
- HIV, Body composition, Weight reduction, Insulin resistance/sensitivity, Exercise, Diet, Visceral adiposity
- Medical subject headings
- HIV Infections, Insulin Resistance, Obesity, Weight Loss, Hypersensitivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss through diet and exerciseBehavioural
Rosiglitazone insulin sensitizing agentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Body composition
Secondary outcomes (4)
Quality of life
Strength and fitness
Lipid profile
Additional cardiovascular risk indicators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJul 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Investigators
- Donald P Kotler, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center, Columbia UniversityJeanine B Albu, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264251
- Sponsor's protocol ID
- SLRHC 02-117
- Status last verified
- Oct 2007
- First submitted
- 9 Dec 2005
- Last updated
- 29 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet, Exercise and Rosiglitazone on Regional Fat and Insulin Resistance in HIV-Infected and Uninfected Men and Women
- ClinicalTrials.gov ID
- NCT00264251
- Acronym / sponsor ID
- SLRHC 02-117
- Conditions
- HIV Infections, Insulin Resistance, Obesity
- Keywords
- HIV, Body composition, Weight reduction, Insulin resistance/sensitivity, Exercise, Diet, Visceral adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Dec 2005 (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 determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are:
- Diet + exercise program.
- Rosiglitazone treatment.
- A combination treatment of diet + exercise program and rosiglitazone.
Detailed description
A constellation of nutritional alterations in HIV-infected patients receiving highly active antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and insulin resistance (IR) has been described. There is a major concern that these developments will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there are well documented associations among body fat distribution, insulin resistance, and adverse health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it is unclear if the relationships are affected by HIV infection, or if they reflect the same outcomes. This information is important, since understanding the interrelationships between body fat distribution and metabolism may guide the development of treatment strategies.
The specific hypotheses to be tested are:
- HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this therapy on insulin resistance.
- HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.
- The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a greater extent than rosiglitazone alone, and will improve insulin resistance to greater extent than diet and exercise alone, however these effects will be blunted in HIV-infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- HIV-infected or uninfected.
- Body mass index (BMI) at least 25.
- Excess visceral adipose tissue. Excess VAT will be determined in HIV+ and HIV- groups of men by a waist hip ratio > 0.95 and a waist circumference >88.2 cm, and in women by a waist:hip >0.9 and waist circumference >75.3 cm.
- Insulin resistance (fasting serum insulin level >16 μU/ml).
Key exclusion criteria (7 listed)
- Unable to tolerate magnetic resonance imaging (MRI)
- Clinical evidence of active liver disease or a significantly abnormal liver function test (ALT >2.5x the upper limit of normal).
- Severe hyperlipidemia (fasting plasma triglycerides >500 mg/dL or fasting total cholesterol >300mg/dL)
- Current coronary artery disease including angina
- Peripheral vascular disease
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 |
|---|---|---|
| Weight loss through diet and exercise | Behavioural | – |
| Rosiglitazone insulin sensitizing agent | Drug | – |
Primary outcome
Insulin sensitivity
Body composition
4 secondary outcomes
Quality of life
Strength and fitness
Lipid profile
Additional cardiovascular risk indicators
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 29 Oct 2007.
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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.
Donald P Kotler, MD principal investigator
St. Luke's-Roosevelt Hospital Center, Columbia University
Jeanine B Albu, MD principal investigator
St. Luke's-Roosevelt Hospital Center, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss through diet and exercise and Rosiglitazone insulin sensitizing agent in people with HIV Infections and Insulin Resistance, run by St. Luke's-Roosevelt Hospital Center 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 4 inclusion and 7 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 29 Oct 2007. 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?
Insulin sensitivity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2007.