Study of Lifestyle Modification in HIV Lipodystrophy

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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 body composition. 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.

Official Title
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The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome

Conditions
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HIV, Metabolic Diseases

Intervention / Treatment
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* Behavioral: Lifestyle Modification
* Other: No lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle Modification<br>Goals derived from the AACE and NCEP-ATP III guidelines and the Diabetes Prevention Program are as follows: <35% calories from fat, < 7% calories from saturated fat, up to 10% calories from polyunsaturated fat, reduction of trans fatty acid intake, up to 20% calories from monounsaturated fat, and 25-35g of fiber per day. 3 hrs of physical activity/week at moderate intensity, >10,000 steps in daily activity, measured by pedometer. The curriculum is modeled after the Diabetes Prevention Program. Subjects will complete lifestyle sessions in the offices of the Program in Nutritional Metabolism or in the Clinical Research Center at MGH with protocol study staff trained to implement the curriculum. | Behavioral: Lifestyle Modification<br> <br> |
| Placebo Comparator: Control<br> | Other: No lifestyle modification<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol |  |  | 
| LDL |  |  | 
| HDL |  |  | 
| triglyceride cholesterol levels |  |  | 
| blood pressure |  |  | 
| cardiac enzymes |  |  | 
| CRP |  |  | 
| t-PA |  |  | 
| PAI |  |  | 
| insulin and glucose metabolism |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, metabolic syndrome