HyperlipidemiaNCT00386971
Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART
A study testing L-carnitine in people with Hyperlipidemia and HIV Infections, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia, HIV Infections
- What is being tested?
- L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women Ages 18-70,
- Stable HAART regimen x 6 mo,
- PI or NNRTI based regimens,
- Caucasian, African American or Hispanic patients
Who cannot join
- 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,
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemia, HIV Infections
- Being tested
- L-carnitine, placebo
- Keywords
- L-carnitine, HIV, TGRL metabolism, postprandial, HIV Treatment Experienced
- Medical subject headings
- Hyperlipidemias, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDietary supplement
3 grams daily in liquid form by mouth
placeboOther
1 oz sweet tasting liquid daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | L-carnitine Receives: Dietary Supplement: L-carnitine |
| 2 | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
L-carnitine supplementation will improve fasting TGRL levels and the postprandial response
Measured: 6 weeks
Secondary outcomes (1)
L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Berglund, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386971
- Sponsor's protocol ID
- 200614280
- Other IDs
- GCRC protocol 109
- Status last verified
- May 2017
- First submitted
- 10 Oct 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART
- ClinicalTrials.gov ID
- NCT00386971
- Acronym / sponsor ID
- 200614280
- Conditions
- Hyperlipidemia, HIV Infections
- Keywords
- L-carnitine, HIV, TGRL metabolism, postprandial, HIV Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: L-carnitineL-carnitine |
| 2 | Placebo comparator | Other: placeboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and Women Ages 18-70,
- Stable HAART regimen x 6 mo,
- PI or NNRTI based regimens,
- Caucasian, African American or Hispanic patients
Key exclusion criteria (11 listed)
- Diabetes Mellitus,
- Liver Disease,uncontrolled
- Pregnant or nursing mothers,
- BMI> 35,
- Hemoglobin <11 g/dl,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitine3 grams daily in liquid form by mouth | Dietary supplement | 1 |
| placebo1 oz sweet tasting liquid daily by mouth | Other | 2 |
Primary outcome
L-carnitine supplementation will improve fasting TGRL levels and the postprandial response
Time frame: 6 weeks
1 secondary outcome
L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Berglund, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine in people with Hyperlipidemia and HIV Infections, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L-carnitine supplementation will improve fasting TGRL levels and the postprandial response (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.