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OpenTrials
Completed

NCT Number: NCT02011100

Effect of Carnosine on 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.

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Key information

Conditions

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Experimental Endocrinology Slovak Academy of Sciences, Bratislava, Slovakia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carnosine

Dietary Supplement

Primary outcomes

  1. oxidative stress

    Time frame: within one year

    AGEs and lipid peroxidation products

  2. chronic systemic inflammation

    Time frame: one year

    circulating hsCRP

Secondary outcomes

  1. level of glucose intolerance

    Time frame: within 10 months

    detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR

Other outcomes

  1. muscle carnosine content

    Time frame: within 9 months

    assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal.

Sponsors and collaborators

Lead sponsor

Jozef Ukropec

Other Gov

Registry information

Official study title

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

Acronym: Carnorisk

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2013
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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