Clinical Trial: Therapeutic Approaches to HAART-Induced Lipodystrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Therapeutic Approaches to HAART-Induced Lipodystrophy

Brief Summary: To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.

Detailed Summary:

Patients with HAART-induced lipodystrophy report loss of subcutaneous (sc) fat from the extremities and face and excess fat accumulation in the neck and truncal region. They also are predisposed to metabolic complications of insulin resistance, such as, dyslipidemia and diabetes mellitus. The pathogenesis of HAART-induced lipodystrophy is not fully understood although PIs have been strongly implicated as the cause. The metabolic complications pose an increased risk of atherosclerosis and acute pancreatitis whereas changes in body fat distribution cause physical discomfort and psychological distress. Management of these problems poses a therapeutic challenge. We propose potentially safe therapeutic lifestyle changes as well as novel therapies for management of HAART-induced lipodystrophy and its metabolic complications. The hypotheses to be tested and the aims are:

Hypothesis 1: A diet rich in cis-monounsaturated fatty acids improves HAART-induced glucose intolerance and dyslipidemia in HIV-infected patients.

Aim 1: To compare acceptability and effects of isocaloric diets rich in carbohydrates and cis-monounsaturated fats, each given for 6 wk, on glucose and lipid metabolism in patients with HAART-induced dyslipidemia in a randomized, cross-over study.

Hypothesis 2: A regimen of aerobic exercise improves insulin resistance, dyslipidemia and body fat distribution in HIV-infected patients with HAART-induced lipodystrophy.

Aim 2: To determine the effects of a supervised aerobic exercise regimen and dietary advice on glucose and lipid metabolism, and body fat distribution in HIV-infected patients with HAART-induced lipodystrophy.

Hypothesis 3: The n-3 polyunsaturated fats improve
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: fasting serum triglycerides [ Time Frame: 6 months ]

Original Primary Outcome: fasting serum triglycerides

Current Secondary Outcome:

  • HDL cholesterol [ Time Frame: 6 months ]
  • LDL cholesterol [ Time Frame: 6 months ]
  • fasting serum glucose [ Time Frame: 6 months ]
  • fasting serum insulin [ Time Frame: 6 months ]
  • overall and regional adiposity [ Time Frame: 6 months ]


Original Secondary Outcome:

  • HDL cholesterol
  • LDL cholesterol
  • fasting serum glucose
  • fasting serum insulin
  • overall and regional adiposity


Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: April 16, 2007
Date Started: January 2003
Date Completion:
Last Updated: June 22, 2015
Last Verified: June 2015