L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration
时间窗: 6 months
Changes in fasting glucose concentration
时间窗: 6 months
Changes in insulin concentration
时间窗: 6 months
次要结局
- Changes in peripheral arterial stiffness(6 months)
- Changes in central blood pressure(6 months)
- Changes in pulse wave velocity(6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 months)
研究者
Pawel Bogdanski
Ass. Prof
Poznan University of Medical Sciences