Diabetes Mellitus, Type 2NCT03193125
Carnitine and Liver Mitochondria Fatty Acid Processing
A study testing L-Carnitine in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral carnitine supplementation modifies mitochondrial fatty acid processing in healthy young adults. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 11 May 2018
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-40 years
- BMI of 24.5-35.5 kg/m2
- Willingness to eat a prescribed diet of standard meals for a total of six days
- Willingness to undergo carnitine or placebo supplementation for two weeks
- Willingness to undergo study procedures including blood draws, MRS, C13 acetate infusion, DXA, muscle biopsy, and consumption of a sugary drink over the course of 6 hours
Who cannot join
- Unstable weight in the last 3 months (gain or loss >7 lb (3.2 kg)
- Significant changes in the diet or level of physical activity within the past month
- Clinical history of diabetes or cancer
- Clinically diagnosed heart, kidney, lung, thyroid, liver disease or abnormal liver enzymes that are, in the opinion of the investigator, clinically significant and represent a problem for study inclusion
- Screening fasting glucose > 125 mg/dL
- Screening blood pressure >140 systolic or >90 diastolic
Show all 19Show fewer
- Use of certain prescribed medications at the discretion of the MI
- Smoking or use of tobacco products in the last 6 months
- Pregnancy or breastfeeding
- Clinically diagnosed neuropsychiatric conditions
- Diets that deviate extremely from the typical western diet in terms of increased meat intake are excluded, at the discretion of the MI.
- Known aversion to or refusal to drink sugary beverages
- Taking any over the counter drugs that alter the intestinal tract, at the discretion of the MI (for example, anti-cholinergic drugs and erythromycin)
- Have taken carnitine supplements regularly in the past 3 months
- Unwilling to discontinue use of dietary supplements containing significant amounts of carnitine or abstain from use one week prior to trial, at the discretion of the MI
- Women who have undergone partial hysterectomy with intact ovarian function
- Standard contra-indications to MRS, including non-removable metallic or electronic implants, claustrophobia or other fear of confinement, or inability to tolerate loud scanner noise
- Calf does not fit into the MRI coil, at the discretion of the PI
- Refusal to allow use of anonymized versions of collected data for research after this study is over
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing
This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral carnitine supplementation modifies mitochondrial fatty acid processing in healthy young adults.
Read the detailed description
This project will use stable isotope techniques and magnetic resonance spectroscopy (MRS) to take a first step toward clarifying how the benefit of oral carnitine supplementation depends on basal mitochondrial fatty acid processing (MFAP) and MFAP modification, with a specific focus on the liver. Approximately 24 healthy young individuals will be enrolled, with 20 expected to complete. Before and after 14 days of oral carnitine supplementation or placebo, MFAP will be measured using measures of acetyl-carnitine concentration (from long-TE proton MRS) and de novo lipogenesis (DNL, from analysis of blood metabolites following 13C-labeled acetate infusion and high-fructose drink challenge). The MFAP measures will be collected before and after loading participants with a high-fructose drink. Fructose is solely metabolized by the liver.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- Being tested
- L-Carnitine, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDietary supplement
500 mg tablets of L-Carnitine taken 3 times daily before meals.
PlaceboDietary supplement
500 mg tablets of L-Carnitine taken 3 times daily before meals.
| Study group | Role | What they receive |
|---|---|---|
| Carnitine | Experimental | 500 mg of L-carnitine to be taken 3 times a day 15 minutes before meals for 14 days. Receives: Dietary Supplement: L-Carnitine |
| Placebo | Placebo comparator | 500 mg of placebo to be taken 3 times a day 15 minutes before meals for 14 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver mitochondrial fatty acid processing
Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge
Measured: Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start15 May 2017
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee, Touro University
- Responsible party
- Principal investigator, Owen Carmichael, Pennington Biomedical Research Center
- Investigators
- Owen Carmichael, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193125
- Sponsor's protocol ID
- PBRC 2016-076
- Status last verified
- Sep 2022
- First submitted
- 16 Jun 2017
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized blood assay results, MRI data, and other de-identified clinical lab data will be shared with other researchers beginning 6 months after study completion. It may be obtained through a written request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing
- ClinicalTrials.gov ID
- NCT03193125
- Acronym / sponsor ID
- PBRC 2016-076
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of Tennessee, Touro University
- Study start
- 15 May 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- 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.
This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral carnitine supplementation modifies mitochondrial fatty acid processing in healthy young adults.
Detailed description
This project will use stable isotope techniques and magnetic resonance spectroscopy (MRS) to take a first step toward clarifying how the benefit of oral carnitine supplementation depends on basal mitochondrial fatty acid processing (MFAP) and MFAP modification, with a specific focus on the liver. Approximately 24 healthy young individuals will be enrolled, with 20 expected to complete. Before and after 14 days of oral carnitine supplementation or placebo, MFAP will be measured using measures of acetyl-carnitine concentration (from long-TE proton MRS) and de novo lipogenesis (DNL, from analysis of blood metabolites following 13C-labeled acetate infusion and high-fructose drink challenge). The MFAP measures will be collected before and after loading participants with a high-fructose drink. Fructose is solely metabolized by the liver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnitine | Experimental | Dietary Supplement: L-Carnitine500 mg of L-carnitine to be taken 3 times a day 15 minutes before meals for 14 days. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo500 mg of placebo to be taken 3 times a day 15 minutes before meals for 14 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-40 years
- BMI of 24.5-35.5 kg/m2
- Willingness to eat a prescribed diet of standard meals for a total of six days
- Willingness to undergo carnitine or placebo supplementation for two weeks
- Willingness to undergo study procedures including blood draws, MRS, C13 acetate infusion, DXA, muscle biopsy, and consumption of a sugary drink over the course of 6 hours
Key exclusion criteria (19 listed)
- Unstable weight in the last 3 months (gain or loss >7 lb (3.2 kg)
- Significant changes in the diet or level of physical activity within the past month
- Clinical history of diabetes or cancer
- Clinically diagnosed heart, kidney, lung, thyroid, liver disease or abnormal liver enzymes that are, in the opinion of the investigator, clinically significant and represent a problem for study inclusion
- Screening fasting glucose > 125 mg/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-Carnitine500 mg tablets of L-Carnitine taken 3 times daily before meals. | Dietary supplement | Carnitine |
| Placebo500 mg tablets of L-Carnitine taken 3 times daily before meals. | Dietary supplement | Placebo |
Primary outcome
Liver mitochondrial fatty acid processing
Time frame: Day 18
Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge
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 29 Sep 2022.
- Individual participant dataSharing planned: Yes. Anonymized blood assay results, MRI data, and other de-identified clinical lab data will be shared with other researchers beginning 6 months after study completion. It may be obtained through a written request to the PI.
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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.
Owen Carmichael, Ph.D. principal investigator
Pennington Biomedical Research Center
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 Diabetes Mellitus, Type 2 and Insulin Resistance, run by Pennington Biomedical Research Center 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 5 inclusion and 19 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 29 Sep 2022. 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?
Liver mitochondrial fatty acid processing (time frame: Day 18). 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 29 Sep 2022.