Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
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Jozef Ukropec
临床试验: NCT02011100
BioSeek: nct02011100
关键词
抽象
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.
日期
| 最后验证: | 03/31/2018 |
| 首次提交: | 12/04/2013 |
| 提交的预估入学人数: | 12/11/2013 |
| 首次发布: | 12/12/2013 |
| 上次提交的更新: | 04/13/2018 |
| 最近更新发布: | 04/17/2018 |
| 实际学习开始日期: | 11/30/2013 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 02/28/2018 |
状况或疾病
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
干预/治疗
Dietary Supplement: Carnosine
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: CARNOSINE 3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1) | |
| Placebo Comparator: placebo 3 months placebo intake - taken twice a day (1-0-1) |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - BMI (28-38 kg.m-2); - waist circumference >94 cm; - % body fat 30% - fasting glycemia < 7 mmol/l Exclusion Criteria: - 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. |
结果
主要结果指标
1. oxidative stress [within one year]
AGEs and lipid peroxidation products
2. chronic systemic inflammation [one year]
circulating hsCRP
次要成果指标
1. level of glucose intolerance [within 10 months]
detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR
其他成果措施
1. muscle carnosine content [within 9 months]
assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal.
