Study of Lifestyle Modification in HIV Lipodystrophy - Full Text View

Purpose

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.

Condition	Intervention
HIV Metabolic Diseases	Behavioral: Lifestyle Modification Other: No lifestyle modification


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

WHR

Secondary Outcome Measures:

total cholesterol
LDL
HDL
triglyceride cholesterol levels
blood pressure
cardiac enzymes
CRP
t-PA
PAI
insulin and glucose metabolism


Estimated Enrollment:	80
Study Start Date:	June 2003
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lifestyle Modification 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
Placebo Comparator: Control	Other: No lifestyle modification

Arms

Assigned Interventions

Active Comparator: Lifestyle Modification

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

Placebo Comparator: Control

Other: No lifestyle modification

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 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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111358

Locations


United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Steven Grinspoon, MD	Massachusetts General Hospital

More Information


Responsible Party:	Steven Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00111358 History of Changes
Other Study ID Numbers:	49302-P1 (completed) R01DK049302
Study First Received:	May 19, 2005
Last Updated:	April 15, 2011
Health Authority:	United States: Federal Government

Keywords provided by Massachusetts General Hospital:


HIV, AIDS, metabolic syndrome

Additional relevant MeSH terms:


Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2016