Effects of L-Carnitine on Postprandial Clearance of Triglyceride-Rich Lipoproteins in HIV Patients on HAART
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/30/2013 |
| Start Date: | October 2006 |
| End Date: | July 2009 |
| Contact: | Alison M Semrad, DO |
| Email: | alison.semrad@ucdmc.ucdavis.edu |
| Phone: | 916-734-9121 |
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.
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.
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
- CKD Stage 3-5,
- Untreated Thyroid Disease,
- Hormone replacement therapy,
- Triglycerides >500 mg/dl (fasting)
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