Obstructive Sleep ApneaCARNIMETNCT02645942
L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea
A study testing L-carnitine in people with Obstructive Sleep Apnea, run by Poznan University of Medical Sciences.
Trial summary
The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- L-carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Feb 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed OSA classified according to the apnea hypopnea index (AHI) as a mild (5.0-14.9), moderate (15.0-29.9), and severe (≥30.0 events per hour),
- treatment with Continuous Positive Airway Pressure (CPAP) for at least 6 months before study screening,
- disturbed lipid metabolism (according to the National Health and Nutrition Examination Survey: LDL-C>100 mg/dl, or TG>150 mg/dl) or use of hypolipidemic drugs,
- disturbed glucose metabolism (Diabetes mellitus or impaired glucose tolerance or impaired fasting glucose) according to American Diabetes Federation or use of hypoglycaemic drugs,
- willingness to participate in the study,
- age over 18,
- continued habitual diet during the study period,
- performance status ≥ 80 according to Karnofsky score
Who cannot join
- newly diagnosed OSA and individuals treated with CPAP,
- other than OSA lung dysfunctions,
- do not use of hypoglycaemic and hypolipidemic drugs,
- modification of hypolipidemic or hypoglycaemic treatment during the study period,
- pregnancy or lactation,
- cancer (excluding curatively treated with no evidence of diseases for 5 years),
Show all 13Show fewer
- severe liver and kidney diseases (Aspartate aminotransferase (ASPAT) and alanine aminotransferase (ALAT) >3 × the upper limit of normal (ULN), Bilirubin >1.5 × ULN, Creatinine >1.5 × ULN),
- known sensitivity to any component of the product,
- diagnosed CVD (myocardial infarct, stroke, angina pectoris).
- an active drug or alcohol abuse,
- legal incompetence,
- limited legal incompetence,
- any uncontrolled medical condition that may put studied patients at high risk during study period
About this study
Official title: L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial
The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.
Read the detailed description
After screening all patients will be randomized in 1:1 ratio to either placebo group or study group (receiving L-C for 8-weeks). Randomization will stratify patients by: age, sex, BMI and severity of OSA. Randomized patients will receive orally either placebo or L-C once a day for 8-weeks. All supplements will be packed in a white box. Because this is a double-blind study, vial labels will contain a unique identification number that will not disclose to the patient or investigator if L-C or matching placebo is included. The daily amount of L-C will be 1400 mg. The detailed composition of the product will be assessed. All patients will receive a test product during the control visits once a month and will be asked to take it once a day in the morning. The completion of the data will be checked during the visits and also via telephone while the study is conducted. All concomitant medications used (including herbal supplements) will be recorded in electronic database. The patients will be asked to continue their habitual diet. Moreover, they will be also advised that they are free to withdraw from participation in this study at any time, for any reason, and without prejudice. The reason for withdrawal and the date of discontinuation will be recorded in our database. Any Adverse Event (AE) will be recorded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE), clinically significant AE, severe laboratory abnormality, intercurrent illness, or other medical condition that indicates that continued administration of study medication is not in the best interest of the patient.
The treatment will be administrated under supervision of experienced nutritionist and medical doctor. The anthropometrical and biochemical measurements with assessment of diet, quality of life and sleep will be completed by the patients at each of the study visits, which will take place at the baseline (screening visit), after 4 weeks, in the post-intervention period (week 8) and at a 6-month follow-up.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- L-carnitine, Placebo
- Keywords
- Carnitine, placebo, risk factors
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDietary supplement
L-carnitine 1400 mg daily for 8 weeks
PlaceboDietary supplement
Placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | L-carnitine 1400 mg daily for 8 weeks Receives: Dietary Supplement: L-carnitine |
| Placebo group | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration
Measured: 6 months
Changes in fasting glucose concentration
Measured: 6 months
Changes in insulin concentration
Measured: 6 months
Secondary outcomes (4)
Changes in central blood pressure
Measured: 6 months
Changes in pulse wave velocity
Measured: 6 months
Changes in peripheral arterial stiffness
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Study stopped due to organization reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Bogdanski, Poznan University of Medical Sciences
- Investigators
- Paweł Bogdański, Ass Prof, MD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645942
- Sponsor's protocol ID
- 962/15
- Acronym
- CARNIMET
- Status last verified
- May 2020
- First submitted
- 29 Dec 2015
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02645942
- Acronym / sponsor ID
- CARNIMET / 962/15
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Carnitine, placebo, risk factors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to organization reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 5 Jan 2016 (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.
The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.
Detailed description
After screening all patients will be randomized in 1:1 ratio to either placebo group or study group (receiving L-C for 8-weeks). Randomization will stratify patients by: age, sex, BMI and severity of OSA. Randomized patients will receive orally either placebo or L-C once a day for 8-weeks. All supplements will be packed in a white box. Because this is a double-blind study, vial labels will contain a unique identification number that will not disclose to the patient or investigator if L-C or matching placebo is included. The daily amount of L-C will be 1400 mg. The detailed composition of the product will be assessed. All patients will receive a test product during the control visits once a month and will be asked to take it once a day in the morning. The completion of the data will be checked during the visits and also via telephone while the study is conducted. All concomitant medications used (including herbal supplements) will be recorded in electronic database. The patients will be asked to continue their habitual diet. Moreover, they will be also advised that they are free to withdraw from participation in this study at any time, for any reason, and without prejudice. The reason for withdrawal and the date of discontinuation will be recorded in our database. Any Adverse Event (AE) will be recorded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE), clinically significant AE, severe laboratory abnormality, intercurrent illness, or other medical condition that indicates that continued administration of study medication is not in the best interest of the patient.
The treatment will be administrated under supervision of experienced nutritionist and medical doctor. The anthropometrical and biochemical measurements with assessment of diet, quality of life and sleep will be completed by the patients at each of the study visits, which will take place at the baseline (screening visit), after 4 weeks, in the post-intervention period (week 8) and at a 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: L-carnitineL-carnitine 1400 mg daily for 8 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed OSA classified according to the apnea hypopnea index (AHI) as a mild (5.0-14.9), moderate (15.0-29.9), and severe (≥30.0 events per hour),
- treatment with Continuous Positive Airway Pressure (CPAP) for at least 6 months before study screening,
- disturbed lipid metabolism (according to the National Health and Nutrition Examination Survey: LDL-C>100 mg/dl, or TG>150 mg/dl) or use of hypolipidemic drugs,
- disturbed glucose metabolism (Diabetes mellitus or impaired glucose tolerance or impaired fasting glucose) according to American Diabetes Federation or use of hypoglycaemic drugs,
- willingness to participate in the study,
Key exclusion criteria (13 listed)
- newly diagnosed OSA and individuals treated with CPAP,
- other than OSA lung dysfunctions,
- do not use of hypoglycaemic and hypolipidemic drugs,
- modification of hypolipidemic or hypoglycaemic treatment during the study period,
- pregnancy or lactation,
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-carnitineL-carnitine 1400 mg daily for 8 weeks | Dietary supplement | Intervention group |
| PlaceboPlacebo daily for 8 weeks | Dietary supplement | Placebo group |
Primary outcome
Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration
Time frame: 6 months
Changes in fasting glucose concentration
Time frame: 6 months
Changes in insulin concentration
Time frame: 6 months
4 secondary outcomes
Changes in central blood pressure
Time frame: 6 months
Changes in pulse wave velocity
Time frame: 6 months
Changes in peripheral arterial stiffness
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Paweł Bogdański, Ass Prof, MD principal investigator
Poznan University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine in people with Obstructive Sleep Apnea, run by Poznan University of Medical Sciences.
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 8 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration (time frame: 6 months). The study lists 3 primary outcomes in all. 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 6 May 2020.