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

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ClinicalTrials.gov Identifier: NCT02011100
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease Dietary Supplement: Carnosine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
Study Start Date : December 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. oxidative stress [ Time Frame: within one year ]
    AGEs and lipid peroxidation products

  2. chronic systemic inflammation [ Time Frame: one year ]
    circulating hsCRP


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011100


Locations
Slovakia
Univeristy Hospital in Bratislava
Bratislava, Slovakia, 81369
Institute of Experimental Endocrinology Slovak Academy of Sciences
Bratislava, Slovakia, 83306
Sponsors and Collaborators
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

Responsible Party: Jozef Ukropec, PhD, Slovak Academy of Sciences
ClinicalTrials.gov Identifier: NCT02011100     History of Changes
Other Study ID Numbers: CarnoDMCVD
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases