Status:
COMPLETED
Study of Lifestyle Modification in HIV Lipodystrophy
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV
Metabolic Diseases
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is designed to determine the effects of an intensive lifestyle modification program in patients with HIV and Metabolic Syndrome. The primary endpoints will be improvement in body compositio...
Detailed Description
This study is designed as a randomized, case-control study of 80 subjects (N=80). Forty subjects will be randomized to the observation group and 40 to the intervention (REACH) group. After two initia...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 and less than or equal to 65 years of age
- HIV+
- Ability and motivation to modify behavior and make lifestyle changes
- 3 out of 5 of the following:
- Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women;
- Triglycerides greater than or equal to 150 mg/dL or current anti-lipolytic drug treatment;
- High-density lipoprotein (HDL) less than 40 mg/dL in men and 50 mg/dL in women;
- Blood pressure greater than or equal to 130/85 mmHg or current antihypertensive drug treatment;
- Fasting glucose greater than or equal to 110 mg/dL.
Exclusion
- History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
- Requiring pharmacological glucocorticoid therapy (\> 7.5mg Prednisone or its equivalent/day)
- Androgen, growth hormone or Megace within 3 months of study initiation. Subjects on a standard dose of testosterone for documented hypogonadism for \> 3 months will be allowed to enter the study.
- New anti-retroviral therapy within 1 month of study initiation
- SGPT \> 5X normal and/or clinically significant liver disease
- Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
- Hemoglobin (Hgb) \< 9 g/dL
- Current drug or alcohol abuse
- History of diabetes mellitus or fasting glucose of greater than or equal to 126 mg/dL
- Current therapy with insulin or other diabetic agent
- Pregnant or actively seeking pregnancy
- Breastfeeding
- Inability to comply with intervention due to lack of motivation, time, social, and/or psychological support
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00111358
Start Date
June 1 2003
End Date
October 1 2006
Last Update
April 18 2011
Active Locations (1)
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1
Mass General Hospital
Boston, Massachusetts, United States, 02114