Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- oxidative stress
研究概览
简要总结
Carnosine is a naturally occurring compound with a potential health benefits. In animal studies, carnosine supplementation reduces manifestation of chronic civilization diseases, regulates subclinical inflammation, protein glycation and lipid & glucose metabolism. Our preliminary data showed the relationship between insulin resistance and carnosine content in human skeletal muscle. Based on these unique results we plan to perform intervention study aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were associated with expression of specific miRNAs. Circulating miRNAs related to carnosine action are unknown. The putative positive effects of carnosine on insulin sensitivity and secretion in obese patients might have a tremendous impact in prevention of type 2 diabetes. Identification of miRNAs associated with carnosine action could provide predictors of successful therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (28-38 kg.m-2);
- •waist circumference >94 cm;
- •% body fat 30%
- •fasting glycemia < 7 mmol/l
排除标准
- •age < 25 or > 50 years,
- •change in body weight > 5 kg in last 12 months,
- •obesity with BMI > 38kg.m-2,
- •previously or newly (oGTT) diagnosed type 2 diabetes,
- •allergy, smoking, alcohol abuse, any pharmacotherapy including regular vitamin intake;
- •cardiovascular, hematologic, respiratory, gastrointestinal, endocrine or oncologic diseases,
- •kidney disease, acute inflammatory disease.
结局指标
主要结局
oxidative stress
时间窗: within one year
AGEs and lipid peroxidation products
chronic systemic inflammation
时间窗: one year
circulating hsCRP
次要结局
- level of glucose intolerance(within 10 months)
研究者
Jozef Ukropec
PhD
Slovak Academy of Sciences