HIV Fat Redistribution and the Evaluation of Brown Fat
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130309095636im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
The specific aims of this study are to determine whether HIV-infected patients with significant fat redistribution and ectopic fat accumulation have increased brown adipose tissue using 18F-FDG Positron Emission Tomography techniques.
Condition |
---|
HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
Official Title: | FDG/PET Imaging for the Assessment of Brown Adipose Tissue in HIV Lipodystrophy |
- Brown Fat [ Time Frame: Baseline ] [ Designated as safety issue: No ]Brown Fat will be assessed by PET FDG
- UCP-1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]UCP-1 will be analyzed from tissue collected from a fat biopsy of dorsocervical spine fat accumulation.
- Indirect Calorimetry [ Time Frame: Baseline ] [ Designated as safety issue: No ]Indirect Calorimetry will be performed to measure resting energy expenditure
- Anthropometrics [ Time Frame: Baseline ] [ Designated as safety issue: No ]Anthropometric measurements of waist to hip ratio, leg circumference, arm circumference and neck circumference will be performed using a standardized technique.
- Glucose tolerance [ Time Frame: Baseline ] [ Designated as safety issue: No ]A baseline glucose level will be obtained and then patients will consume a 75g glucose beverage. Subjects must complete the beverage within 5-10 minutes. Subsequently, blood glucose at +30, +60, +90, and +120 minutes, insulin levels will be assessed at baseline and +120 minutes. Glucose tolerance will be calculated by insulin area under the curve in response to OGTT.
Biospecimen Retention: Samples Without DNA
Blood tests will include a complete blood count, creatinine, SGPT TSH and Free T4, triglyceride, total, HDL and LDL cholesterol, HIV test, CD4 count (for HIV+ subjects only), HIV viral load (for HIV+ subjects only), fasting glucose, 2 hour OGTT, as well as tissue samples from fat biopsy.
Enrollment: | 21 |
Study Start Date: | March 2010 |
Study Completion Date: | October 2011 |
Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
HIV-infection with fat redistribution (lipoatrophy)
|
Healthy controls
|
HIV-infected with fat redistribution (lipohypertrophy)
|
Detailed Description:
Among individuals infected with HIV, highly active antiretroviral therapy has reduced the incidence of morbidity and mortality however, despite recent improvements in newer antiretrovirals patients continue to exhibit secondary effects related to body composition such as lipoatrophy of the periphery, increased adiposity of the trunk and lipomatosis, especially of the dorsocervical spine. Changes in body composition have been reported in 40-50% of HIV-infected patients. Several studies have shown that antiretroviral therapy contributes to changes in body composition and is coupled with increased dyslipidemia, insulin resistance and diabetes.
Accumulation of fat over the dorsocervical spine, or "buffalo" has been reported in 2% to 13% of HIV-infected patients. Enlargement of adipose tissue in the dorsocervical region involves subcutaneous fat and is therefore unique to fat accumulation of the abdominal area. Guallar et al. examined dorsocervical adipose tissue after surgical removal and found that adipose tissue in this area showed substantial levels of the marker gene of brown fat, uncoupling protein 1 (UCP-1) suggesting there may be brown adipose tissue (BAT) in HIV infected individuals with lipomatosis of the dorsocervical spine. Until recently, BAT was known to be present in rodents throughout their lifetime and was thought to be present in humans only during infancy and early childhood. However, recent studies using 18F-FDG PET-CT have confirmed the presence of BAT in adults. Brown adipose tissue is known to affect whole-body metabolism and may be related to insulin sensitivity as well as susceptibility to weight gain.
Using 18F-FDG PET techniques, our group has evaluated HIV-infected subjects with lipoatrophy and noted there was significantly increased glucose uptake into subcutaneous tissue which may suggest presence of BAT in HIV-infected patients. However our previous study did not specifically examine areas of BAT in the subjects. Therefore, using 18F-FDG PET-CT in addition to fat biopsies we propose to explore the presence of BAT in fat depots among HIV-infected patients with fat redistribution, focusing specifically in the cervical area.
![](https://webarchive.library.unt.edu/web/20130309095636im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV infected patients with fat redistribution and non HIV controls
Subject Selection and Enrollment:
Twenty male subjects comprised of four distinct groups will be recruited for the study. Subjects will be matched by age and body-mass index. The four groups are:
Group 1: HIV infected with fat redistribution (lipohypertrophy) (n=5) Group 2: HIV infected with fat redistribution (lipoatrophy) (n=5) Group 3: Healthy Controls (n=10)
Inclusion Criteria for HIV+ with fat redistribution (lipohypertrophy) subjects (Group 1)
- Evidence of HIV infection
- Age ≥ 20 and ≤ 60 years of age
- BMI measurement between 25-29.9 kg/m2
- HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
- Evidence of significant fat redistribution rated by the investigator, including 1) significant fat atrophy of the face, arms or legs, and 2) significant increase in fat accumulation of the neck.
Exclusion Criteria for HIV+ with fat redistribution (lipohypertrophy) (Group 1)
- Hemoglobin < 10.0 g/dL
- Diabetes or on medications for diabetes
- Abnormal thyroid function
- Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
- Chronic adrenergic drug use (>3 months) and benzodiazepine use.
- Therapy with glucocorticoids (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Other serious or chronic diseases
- New antiretroviral regimen in the past 12 months
- Any new serious opportunistic infection within the past 6 weeks
Inclusion Criteria for HIV+ with fat redistribution (lipoatrophy) (Group 2)
- Evidence of HIV infection
- Age ≥ 20 and ≤ 60 years of age
- BMI measurement between 18-24 kg/m2
- HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
- No evidence of fat redistribution rated by the investigator.
Exclusion Criteria for HIV+ with fat redistribution (lipoatrophy) (Group 2)
- Hemoglobin < 10.0 g/dL
- Diabetes or on medications for diabetes
- Abnormal thyroid function
- Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
- Chronic adrenergic drug use (>3 months) and benzodiazepine use.
- Therapy with glucocorticoids (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Other serious or chronic diseases
- New antiretroviral regimen in the past 12 months
- Any new serious opportunistic infection within the past 6 weeks
Inclusion Criteria for Healthy Controls (Group 3)
- No history of HIV infection
- Age ≥ 20 and ≤ 60 years of age
- BMI measurement between 18-29.9 kg/m2
Exclusion Criteria for Healthy Controls (Group 3)
- Hemoglobin <10.0 g/dL.
- Diabetes or on medications for diabetes
- Abnormal thyroid function.
- Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
- Chronic adrenergic drug use (>3 months) and benzodiazepine use.
- Therapy with glucocorticoid (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any history of serious or chronic diseases -
![](https://webarchive.library.unt.edu/web/20130309095636im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
Study Director: | Martin Torriani, MD | Massachusetts General Hopsital |
![](https://webarchive.library.unt.edu/web/20130309095636im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01098045 History of Changes |
Other Study ID Numbers: | 2009P-001836 |
Study First Received: | March 25, 2010 |
Last Updated: | May 3, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
HIV fat redistribution brown adipose tissue PET |
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 |
ClinicalTrials.gov processed this record on March 07, 2013