Study of Lifestyle Modification in HIV Lipodystrophy

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111358
• Other study ID #: 49302-P1 (completed)
• Secondary ID: R01DK049302
• Status: Completed
• Phase: N/A
• First received: May 19, 2005
• Last updated: April 15, 2011
• Start date: June 2003
• Est. completion date: October 2006

Study information

• Verified date: April 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Metabolic Diseases

Intervention

Behavioral:
• Lifestyle Modification

Other:
• No lifestyle modification

Locations

Country	Name	City	State
United States	Mass General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHR
Secondary	total cholesterol
Secondary	LDL
Secondary	HDL
Secondary	triglyceride cholesterol levels
Secondary	blood pressure
Secondary	cardiac enzymes
Secondary	CRP
Secondary	t-PA
Secondary	PAI
Secondary	insulin and glucose metabolism