Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

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StatusTamamlandı

Sponsorlar

Jozef Ukropec

KLINIK SINAQ: NCT02011100

BioSeek: nct02011100

Açar sözlər

Mücərrəd

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.

Tarixlər

Son Doğrulandı:	03/31/2018
İlk təqdim:	12/04/2013
Təxmini qeydiyyat təqdim edildi:	12/11/2013
İlk Göndərmə:	12/12/2013
Son Yeniləmə Göndərildi:	04/13/2018
Son Yeniləmə Göndərildi:	04/17/2018
Həqiqi Təhsilin Başlama Tarixi:	11/30/2013
Təxmini İlkin Tamamlanma Tarixi:	11/30/2017
Təxmini İşin Tamamlanma Tarixi:	02/28/2018

Vəziyyət və ya xəstəlik

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Müdaxilə / müalicə

Dietary Supplement: Carnosine

Faza

Qol Qrupları

Qol	Müdaxilə / müalicə
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)

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	25 Years Üçün 25 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	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.

Nəticə

İlkin nəticə tədbirləri

1. oxidative stress [within one year]

AGEs and lipid peroxidation products

2. chronic systemic inflammation [one year]

circulating hsCRP

İkincili Nəticə Tədbirləri

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

Digər nəticə tədbirləri

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.

Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Açar sözlər

i̇ltihab

diabetes mellitus type 2

insulin resistance

köklük

carnosine