Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
• Interventions: Dietary Supplement: Carnosine

• Registration Number: NCT02011100
• Lead Sponsor: Jozef Ukropec

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-14
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Carnosine	3 months placebo intake - taken twice a day (1-0-1)
CARNOSINE	Carnosine	3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)

Primary Outcome Measures

Name	Time	Method
oxidative stress	within one year	AGEs and lipid peroxidation products
chronic systemic inflammation	one year	circulating hsCRP

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Univeristy Hospital in Bratislava; 🇸🇰 Bratislava, Slovakia

Institute of Experimental Endocrinology Slovak Academy of Sciences; 🇸🇰 Bratislava, Slovakia