Effect of Carnosine on Diabetes and Cardiovascular Risk Factors (Carnorisk)

Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Carnosine

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 81369
    • Univeristy Hospital in Bratislava
  • Bratislava, Slovakia, 83306
    • Institute of Experimental Endocrinology Slovak Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARNOSINE; 3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)	Dietary supplement: Carnosine
Placebo Comparator: placebo; 3 months placebo intake - taken twice a day (1-0-1)	Dietary supplement: Carnosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxidative stress	AGEs and lipid peroxidation products	within one year
chronic systemic inflammation	circulating hsCRP	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of glucose intolerance	detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR	within 10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle carnosine content	assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal.	within 9 months

Collaborators and Investigators

• Sponsor: Jozef Ukropec
• Investigators: Principal Investigator: Jozef Ukropec, PhD, Institute of Experimental Endocrinology SAS; Study Director: Barbara Ukropcova, MD, PhD, Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SAS; Study Chair: Boris Krahulec, MD, PhD, University Hospital in Bratislava; Study Chair: Barbora deCourten, MD, MPH, PhD, FRACP, Monash University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 14, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Metabolic Diseases
• Other Study ID Numbers: CarnoDMCVD