- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386971
Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- GCRC UC Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
1 oz sweet tasting liquid daily by mouth
|
Active Comparator: 1
L-carnitine
|
3 grams daily in liquid form by mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
L-carnitine supplementation will improve fasting TGRL levels and the postprandial response
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Berglund, MD, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200614280
- GCRC protocol 109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on L-carnitine
-
Gdansk University of Physical Education and SportMedical University of GdanskCompleted
-
Gdansk University of Physical Education and SportMedical University of GdanskCompleted
-
Ain Shams UniversityCompleted
-
Vanderbilt University Medical CenterCompletedLung Diseases | Pulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Primary Pulmonary Hypertension | Carnitine Nutritional DeficiencyUnited States
-
Toujinkai HospitalCompletedDisorder of Fatty Acid Metabolism
-
Bahria UniversityUniversity of Karachi; Jinnah Postgraduate Medical Centre; Pakistan Navy Station...RecruitingHemodialysis ComplicationPakistan
-
HealthPartners InstituteTerminatedBreast Cancer | Neurotoxicity | Chemotherapeutic Agent ToxicityUnited States
-
National Taiwan University HospitalRecruitingGut Dysbiosis for TMAO Production From L-carnitine ConsumptionTaiwan
-
Ain Shams UniversityActive, not recruitingl Carnitine With Ketogenic DietEgypt
-
Heba Allah Ali Abd El-Halim MabroukTanta UniversityCompleted