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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 134-140

L-carnitine for reducing cardio-metabolic risk in patients with obstructive sleep apnea: study protocol of a randomized, double-blind, placebo-controlled trial


1 Department of Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; Department of Paediatric Gastroenterology and Metabolic Disorders, Poznan University of Medical Sciences, Poznan, Poland
2 Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences, Poznan, Poland
3 Department of Human Nutrition and Hygiene, Poznan University of Life Sciences, Poznan, Poland
4 Department of Paediatric Gastroenterology and Metabolic Disorders, Poznan University of Medical Sciences, Poznan, Poland
5 Department of Pulmonology, Alergology and Respiratory Oncology, Poznan University of Medical Sciences, Poznan, Poland

Correspondence Address:
Marta Stelmach-Mardas
Department of Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; Department of Paediatric Gastroenterology and Metabolic Disorders, Poznan University of Medical Sciences, Poznan, Poland

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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5658.191356

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Background: Dyslipidemia and insulin resistance are diagnosed very often in obstructive sleep apnea patients; therefore the novel therapies based on the components involved in lipid and carbohydrates metabolism are still being searched for. L-carnitine may play a positive role in energy metabolism and in the reduction of cardio-metabolic risk factors. The present trial aims to investigate the potential role of L-carnitine in lipid and carbohydrates metabolism with precision non-invasive measurements in obstructive sleep apnea patients. Methods/Design: This ongoing study is a randomized, double-blind, placebo controlled, 2-arm parallel-group trial. A total of 80 eligible patients aged 18-80 with obstructive sleep apnea will be randomized in a 1:1 ratio to receive either placebo (placebo group) or L-carnitine (study group) for 8 weeks. Primary outcome measures are changes in lipid and carbohydrates metabolism. Secondary outcome are changes in non-invasive haemodynamic measurements: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) will be assessed. All outcome measures will be assessed at baseline, 4, 8 weeks, and 6 months post-intervention. Discussion: The novelty of this randomized controlled trial is the supplementation of L-carnitine connected with a mobile application for measuring medication adherence. Combined application of non-invasive haemodynamic measurement with assessment of lipid and glucose metabolism will allow us to examine the potential merit of routine supplementation of L-carnitine in patients suffering from obstructive sleep apnea. Trial registration: ClinicalTrials.gov identifier: NCT02645942, registered on 29 December 2015. Ethics: This trial has been approved by Bioethical Committee at Poznan University of Medical Sciences (approval No. 962/15) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from each patient prior to the trial.


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