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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386971
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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 or disease Intervention/treatment Phase
Hyperlipidemia HIV Infections Dietary Supplement: L-carnitine Other: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART
Study Start Date : October 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: 1
Dietary Supplement: L-carnitine
3 grams daily in liquid form by mouth

Placebo Comparator: 2
Other: placebo
1 oz sweet tasting liquid daily by mouth

Primary Outcome Measures :
  1. L-carnitine supplementation will improve fasting TGRL levels and the postprandial response [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386971

United States, California
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Lars Berglund, MD, PhD University of California, Davis

Responsible Party: University of California, Davis Identifier: NCT00386971     History of Changes
Other Study ID Numbers: 200614280
GCRC protocol 109
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
TGRL metabolism
HIV Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases