Trial record 11 of 27 for:    " March 17, 2010":" April 16, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Fat Redistribution and the Evaluation of Brown Fat

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01098045
First received: March 25, 2010
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Brown Fat [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Brown Fat will be assessed by PET FDG


Secondary Outcome Measures:
  • 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)
  1. Evidence of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 18-24 kg/m2
  4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
  5. No evidence of fat redistribution rated by the investigator.
Healthy controls
  1. No history of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 18-29.9 kg/m2
HIV-infected with fat redistribution (lipohypertrophy)
  1. Evidence of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 25-29.9 kg/m2
  4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
  5. 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV infected patients with fat redistribution and non HIV controls

Criteria

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)

  1. Evidence of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 25-29.9 kg/m2
  4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
  5. 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)

  1. Hemoglobin < 10.0 g/dL
  2. Diabetes or on medications for diabetes
  3. Abnormal thyroid function
  4. Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
  5. Chronic adrenergic drug use (>3 months) and benzodiazepine use.
  6. Therapy with glucocorticoids (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
  7. Current substance abuse, including alcohol, cocaine and/or heroin
  8. Other serious or chronic diseases
  9. New antiretroviral regimen in the past 12 months
  10. Any new serious opportunistic infection within the past 6 weeks

Inclusion Criteria for HIV+ with fat redistribution (lipoatrophy) (Group 2)

  1. Evidence of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 18-24 kg/m2
  4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months
  5. No evidence of fat redistribution rated by the investigator.

Exclusion Criteria for HIV+ with fat redistribution (lipoatrophy) (Group 2)

  1. Hemoglobin < 10.0 g/dL
  2. Diabetes or on medications for diabetes
  3. Abnormal thyroid function
  4. Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
  5. Chronic adrenergic drug use (>3 months) and benzodiazepine use.
  6. Therapy with glucocorticoids (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
  7. Current substance abuse, including alcohol, cocaine and/or heroin
  8. Other serious or chronic diseases
  9. New antiretroviral regimen in the past 12 months
  10. Any new serious opportunistic infection within the past 6 weeks

Inclusion Criteria for Healthy Controls (Group 3)

  1. No history of HIV infection
  2. Age ≥ 20 and ≤ 60 years of age
  3. BMI measurement between 18-29.9 kg/m2

Exclusion Criteria for Healthy Controls (Group 3)

  1. Hemoglobin <10.0 g/dL.
  2. Diabetes or on medications for diabetes
  3. Abnormal thyroid function.
  4. Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
  5. Chronic adrenergic drug use (>3 months) and benzodiazepine use.
  6. Therapy with glucocorticoid (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
  7. Current substance abuse, including alcohol, cocaine and/or heroin
  8. Any history of serious or chronic diseases -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098045

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
Study Director: Martin Torriani, MD Massachusetts General Hopsital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014