Study of Lifestyle Modification in HIV Lipodystrophy
Completed · Not applicable
Conditions studied: HIV, Metabolic Diseases
In brief
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 composition, specifically waist-to-hip ratio (WHR). The secondary endpoints will include improvement of cardiovascular indices, such as total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride cholesterol levels, blood pressure, cardiac enzymes, c-reactive protein (CRP), tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI), and insulin and glucose metabolism. We expect that quality of life indices and life skills should also improve with the lifestyle modification program.
Key facts
- Study ID
- NCT00111358
- Run by
- Massachusetts General Hospital
- People needed
- 80
- Starts
- 2003-06-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2011-04-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mass General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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