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.
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)
After two initial screening visits with medical and nutrition staff for informed consent,
determination of eligibility, and evaluation of a 7-day food record, qualifying patients
will be seen for a baseline visit. A nutrition questionnaire and bioimpedance analysis
(BIA) testing will be done at the first screening visit, and sub-maximal stress testing and
other tests with physical therapy will be done at the second screening visit.
At baseline, patients will have an interval history and physical exam, lipodystrophy
evaluation by the investigator (objective) and patient (subjective) report, blood tests and
Nearly identical visits to that at baseline, with the addition of the sub-maximal stress
test, and other physical therapy testing, will be repeated at 6 and 12 months. Carotid
ultrasound will be repeated at the 6 and 12 month visits. There will also be a short visit
at 3 and 9 months to obtain an interval history and physical exam, safety labs, and a 7-day
food record for an Intake Report.
At baseline, patients will be randomized to either the observation group or the lifestyle
intervention, known as "Reach for Energy, Activity, and Cardiovascular Health" (REACH).
Randomization will be stratified for gender and fasting glucose < or >= 110 mg/dL.
Those randomized to observation will receive a one time counseling session with nutrition
staff at the baseline visit and monthly, unscripted phone calls from the
investigator/co-investigator, and come in for regular study visits at 3, 6, 9, and 12
months, as described above.
Those randomized to REACH will attend one-on-one counseling sessions with a trained
dietitian covering the "core-curriculum" that is modeled after the Diabetes Prevention
Program (DPP) study 16 week core curriculum intervention.
- Age greater than or equal to 18 and less than or equal to 65 years of age
- 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
- Triglycerides greater than or equal to 150 mg/dL or current anti-lipolytic drug
- 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
- Fasting glucose greater than or equal to 110 mg/dL.
- 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
- 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
- Inability to comply with intervention due to lack of motivation, time, social, and/or