Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
This trial is active, not recruiting.
|Condition||metabolic diseases, type 2 diabetes, cardiovascular disease|
|Start date||December 2013|
|End date||December 2014|
|Trial size||30 participants|
|Trial identifier||NCT02011100, CarnoDMCVD|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
|Primary purpose||basic science|
3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)
3 months placebo intake - taken twice a day (1-0-1)
time frame: within one year
chronic systemic inflammation
time frame: one year
level of glucose intolerance
time frame: within 10 months
Male or female participants from 25 years up to 50 years old.
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.
|Official title||Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors|
|Principal investigator||Jozef Ukropec, PhD|
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