Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Skeletal muscle total carnitine content
研究概览
简要总结
A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance). Insulin resistance can be caused by the accumulation of fat within muscle of overweight individuals. The aim of the present research is to test whether a novel nutritional intervention containing L-carnitine can increase the amount of carnitine within muscle of individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat' within our muscles and it is hoped that increasing the amount of carnitine within muscle can increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying any observed effects in a hope to identify further targets to lower muscle fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 27-37 kg/m2
- •Age 18-60 years old
- •Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone
- •Not taking anti-diabetes medication other than metformin
- •Understand verbal and/or written explanation of the study requirements
排除标准
- •Malignancy (excluding localised basal and squamous cell skin cancer)
- •Metabolic diseases (stable treated hypothyroidism allowed)
- •Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months)
- •Primary muscle disorders
- •Cerebrovascular disease
- •Neurological disease e.g. epilepsy, Parkinsons disease
- •Active respiratory disease
- •Active gastrointestinal or liver disease
- •Renal impairment (eGFR <60 ml/min)
- •Clotting dysfunction
- •Anti-diabetes medication other than metformin
- •Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
- •Any other conditions in addition to the above that the investigators consider may affect study measurements or safety
结局指标
主要结局
Skeletal muscle total carnitine content
时间窗: up to 24 weeks of L-carnitine supplementation
次要结局
未报告次要终点