Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea (CARNIMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02645942
Recruitment Status : Withdrawn (Study stopped due to organization reasons.)
First Posted : January 5, 2016
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Pawel Bogdanski, Poznan University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Dietary Supplement: L-carnitine Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Intervention group
L-carnitine 1400 mg daily for 8 weeks
Dietary Supplement: L-carnitine
L-carnitine 1400 mg daily for 8 weeks

Placebo Comparator: Placebo group
Placebo
Dietary Supplement: Placebo
Placebo daily for 8 weeks




Primary Outcome Measures :
  1. Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration [ Time Frame: 6 months ]
  2. Changes in fasting glucose concentration [ Time Frame: 6 months ]
  3. Changes in insulin concentration [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes in central blood pressure [ Time Frame: 6 months ]
  2. Changes in pulse wave velocity [ Time Frame: 6 months ]
  3. Changes in peripheral arterial stiffness [ Time Frame: 6 months ]
  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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),
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645942


Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Paweł Bogdański, Ass Prof, MD Poznan University of Medical Sciences
Layout table for additonal information
Responsible Party: Pawel Bogdanski, Ass. Prof, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02645942    
Other Study ID Numbers: 962/15
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawel Bogdanski, Poznan University of Medical Sciences:
Carnitine
placebo
risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases