Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00572429

Effects of Mixed Exercise Regime and L-Carnitine Supplementation in HIV Patients on HAART

Effects of Mixed Exercise Regime and L-Carnitine Supplementation on Kinetics of Triglyceride-rich Lipoproteins in HIV Patients on HAART

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

HIV patients treated with Highly Active AntiRetroviral Therapy (HAART) show significant metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible contribution to these symptoms in HIV/HAART is a decrease in mitochondrial function, resulting in a decreased fatty acid oxidation. A combined regime of aerobic and resistance training has been demonstrated to increase lean body mass and reduce overall fat and truncal fat and the levels of triglyceride and LDL cholesterol.

Detailed description

The introduction of Highly Active AntiRetroviral Therapy (HAART) for AIDS and HIV has improved survival considerably. However, HIV patients treated with HAART show significant metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible contribution to these dysmetabolic symptoms in HIV/HAART is a decrease in mitochondrial function, resulting in a decreased fatty acid oxidation. Life style modulation such as aerobic exercise and L-carnitine supplementation may be beneficial to mitochondrial function. Aerobic exercise improves the biogenesis and function of mitochondria. A combined regime of aerobic and resistance training has been demonstrated to increase lean body mass and reduce overall fat and truncal fat and the levels of triglyceride and LDL cholesterol. L-Carnitine plays an important role in the transfer of long-chain acyl groups into the mitochondrial matrix and potentially improves energy metabolism. Further, L-carnitine supplementation decreases serum triglyceride levels in HIV/HAART patients with hypertriglyceridemia. However, little is known whether these life style modulations act synergistically in HIV/HAART patients. We hypothesize that a mixed regimen of exercise (including both resistance and aerobic exercise) and L-carnitine supplementation will improve mitochondrial dysfunction in HIV/HAART patients, and therefore, alleviate dysmetabolic symptoms such as dyslipidemia and insulin resistance. In this randomized, placebo-controlled study, we will explore whether a mixed regimen of exercise, including both resistance and aerobic exercise, and L-carnitine supplementation affect lipids and remnant lipoproteins, adipokines, insulin resistance; blood lactate levels and VO2max; and kinetics of leucine and triglyceride-rich lipoproteins among African-American and Hispanic HIV-positive subjects undergoing HAART. Effects on muscle mitochondrial function will be assessed using exercise tests and body composition assessment (DEXA and Bioimpedance), while effects on hepatic mitochondrial function will be assessed measuring the relation between leucine and VLDL-apoB metabolism. We believe that the proposed study will help to elucidate underlying mechanisms for metabolic complications and will offer new possibilities for intervention to reduce negative metabolic effects in HIV/HAART patients.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTl-carnitine3 gram daily dose

Timeline

Start date
2008-07-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2007-12-13
Last updated
2012-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00572429. Inclusion in this directory is not an endorsement.