Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lars Berglund, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00386971
First received: October 10, 2006
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

Included in this study will be patients with HIV and being treated with highly active antiretroviral medications (HAART) including protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI). Protease inhibitors and non-nucleoside reverse transcriptase inhibitors are very common medications in HIV treatment and are usually given with other medications as part of a standard treatment for HIV (HAART).

We hope to learn more about how the levels of cholesterol-and triglyceride-carrying particles (lipoproteins) are affected by a nutritional supplement, L-Carnitine, in HIV-positive patients treated with antiretroviral medications.


Condition Intervention
Hyperlipidemia
HIV Infections
Dietary Supplement: L-carnitine
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART

Resource links provided by NLM:


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

Primary Outcome Measures:
  • L-carnitine supplementation will improve fasting TGRL levels and the postprandial response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
L-carnitine
Dietary Supplement: L-carnitine
3 grams daily in liquid form by mouth
Placebo Comparator: 2
Placebo
Other: placebo
1 oz sweet tasting liquid daily by mouth

Detailed Description:

The postprandial state is a proinflammatory and proatherogenic condition. Increasing evidence support the contention the elevated triglyceride (TG)-rich lipoproteins (TGRL) are atherogenic. Hypertriglyceridemia is a characteristic of the metabolic complications during human immunodeficiency virus/highly active antiretroviral therapy (HIV/HAART) and the increased postprandial lipemia commonly seen in this situation may convey an increased cardiovascular risk. A possible contribution to the hypertriglyceridemia in HIV/HAART may be a decrease in mitochondrial function, resulting in a decreased fatty acid oxidation. A decrease in mitochondrial function may also contribute to insulin resistance. L- Carnitine plays an important role in the transfer of long-chain acyl groups into the mitochondrial matrix and potentially improves energy metabolism. L- Carnitine has been shown to reduce hypertriglyceridemia during HAART in HIV-positive subjects, but virtually nothing is known about its effect in the postprandial state. We have experience from postprandial studies in HAART-treated HIV-positive African American and Hispanic subjects, where we have focused on the relationship between lipids, fatty acids, insulin and adipokines. This is of particular relevance among African Americans, where key metabolic components differ substantially from levels in Caucasians. Further, the relationship between metabolic parameters and HIV/HAART is far less explored in this ethnic group. We recently found a proportional relationship between insulin and non-esterified fatty acids (NEFA) in response to food among African American HIV-positive subjects. Further, we showed a relationship between fasting insulin and postprandial adipokine levels.

In this randomized, double blind placebo-controlled pilot study, we will explore whether L- Carnitine affects TGRL metabolism in the fasting and the postprandial states among African American and Hispanic HIV-positive subjects undergoing antiretroviral therapy.

We hypothesize: (1) that L- Carnitine supplementation will improve both fasting TGRL levels and the postprandial response, and (2) that L- Carnitine will impact on the relationship between insulin and NEFA or adipokines in the postprandial state.

In our specific aims, we will test the effect of L- Carnitine supplementation on:

  • Baseline TGRL metabolism and insulin, NEFA and adipokine levels
  • Postprandial TGRL responses and the postprandial relationship between insulin and non-esterified fatty acids (NEFA) and adipokines We believe that the results generated from the proposed studies will help to evaluate effects of L- Carnitine supplementation on postprandial TGRL-associated cardiovascular risks.
  Eligibility

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

Inclusion Criteria:

  • Men and Women Ages 18-70,
  • Stable HAART regimen x 6 mo,
  • PI or NNRTI based regimens,
  • Caucasian, African American or Hispanic patients

Exclusion Criteria:

  • Diabetes Mellitus,
  • Liver Disease,uncontrolled
  • Pregnant or nursing mothers,
  • BMI> 35,
  • Hemoglobin <11 g/dl,
  • Conditions known to lower seizure threshold (ie. brain tumor) or taking medications that lower seizure threshold,
  • Patients taking: Warfarin, ValproicAcid or Zidovudine,Wellbutrin or Effexor
  • Chronic Kidney Disease Stage 3-5,
  • Untreated Thyroid Disease,
  • Hormone replacement therapy,
  • Triglycerides >500 mg/dl (fasting)
  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: NCT00386971

Locations
United States, California
GCRC UC Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Lars Berglund, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Lars Berglund, MD, Professor, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00386971     History of Changes
Other Study ID Numbers: 200614280, GCRC protocol 109
Study First Received: October 10, 2006
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
L-carnitine
HIV
TGRL metabolism
postprandial
HIV Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hyperlipidemias
Dyslipidemias
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Carnitine
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014