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

This study has been withdrawn prior to enrollment.
(no subjects enrolled,study never started)
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00572429
First received: December 11, 2007
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
HIV Infections
Hyperlipidemia
Exercise
 Dietary Supplement: l-carnitine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Mixed Exercise Regime and L-Carnitine Supplementation on Kinetics of Triglyceride-rich Lipoproteins in HIV Patients on HAART

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Exercise and L-carnitine supplementation will reduce blood lactate levels, increase the VO2sub-max and the VLDL to leucine enrichment ratio in HIV/HAART patients, suggesting an overall improvement of muscle and hepatic mitochondrial function. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Enrollment: 0
Study Start Date: July 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Dietary Supplement: l-carnitine
3 gram daily dose

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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American, Hispanic and Caucasian adults with HIV on a stable HAART regimen (either PI or NNRTI based) for at least the past 6 months between 18 to 70 years of age.
  • Patients taking SSRI's (Selective Serotonin Reuptake Inhibitors), SNRI's (Serotonin/Norepinephrine Reuptake inhibitors) and Tetracyclic antidepressants will be included as the risk of seizure in these patients in combination with the L-Carnitine supplement would be rare. Patients on these medications should be on a stable dose for at least 4-6 months prior to enrollment in the study.

Exclusion Criteria:

  • Diabetes Mellitus
  • Cushing's syndrome
  • Renal disease (i.e. CKD Stages 3-5)
  • Unstable liver disease
  • Untreated thyroid dysfunction
  • Seizure disorder
  • Patients with conditions that can lower seizure threshold (i.e. brain tumors) or are taking medication(s) known to lower seizure threshold
  • Pregnant or nursing mothers
  • BMI > 35
  • Ongoing hormone replacement therapy
  • Hemoglobin levels less than 11 g/dl, and fasting triglyceride levels > 500 mg/dl.
  • Subjects with ongoing hypolipidemic and warfarin therapy will be excluded. Additionally, patients taking Valproic Acid and / or Zidovudine will be excluded as these have been shown to deplete carnitine.
  • Patients taking Venlafaxine and Bupropion will be excluded as these medications have a small risk (0.26% and 0.1-0.4% risk, respectively) of causing seizure in patients without a previous risk of seizure.
  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: NCT00572429

Locations
United States, California
CARES
Sacramento, California, United States, 95814
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Lars Berglund, MD, PhD UC Davis Health System
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00572429     History of Changes
Other Study ID Numbers: 200715081
Study First Received: December 11, 2007
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
HIV/AIDS
HAART
high cholesterol
 exercise
L-carnitine
Complimentary therapies

Additional relevant MeSH terms:
Carnitine
Growth Substances
Micronutrients
Pharmacologic Actions
 Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on March 03, 2015