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

Study Overview
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Brief Summary
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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
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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.

Official Title
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L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Dietary Supplement: L-carnitine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>L-carnitine 1400 mg daily for 8 weeks | Dietary Supplement: L-carnitine<br>* L-carnitine 1400 mg daily for 8 weeks<br>|
| Placebo Comparator: Placebo group<br>Placebo | Dietary Supplement: Placebo<br>* Placebo daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration |  | 6 months | 
| Changes in fasting glucose concentration |  | 6 months | 
| Changes in insulin concentration |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in central blood pressure |  | 6 months | 
| Changes in pulse wave velocity |  | 6 months | 
| Changes in peripheral arterial stiffness |  | 6 months | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carnitine, placebo, risk factors