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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Slovak Academy of Sciences
Sponsor:
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences
ClinicalTrials.gov Identifier:
NCT02011100
First received: December 5, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Dietary Supplement: Carnosine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Slovak Academy of Sciences:

Primary Outcome Measures:
  • oxidative stress [ Time Frame: within one year ] [ Designated as safety issue: No ]
    AGEs and lipid peroxidation products

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


Secondary Outcome Measures:
  • level of glucose intolerance [ Time Frame: within 10 months ] [ Designated as safety issue: No ]
    detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR


Other Outcome Measures:
  • muscle carnosine content [ Time Frame: within 9 months ] [ Designated as safety issue: No ]
    assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal.


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011100

Contacts
Contact: Barbara Ukropcova, MD, PhD +421-2-5477-2800 ext 254 barbara.ukropcova@savba.sk
Contact: Jozef Ukropec, PhD +421-2-5477-2800 ext 205 jozef.ukropec@savba.sk

Locations
Slovakia
Institute of Experimental Endocrinology Slovak Academy of Sciences Recruiting
Bratislava, Slovakia, 83306
Contact: Barbara Ukropcova, MD, PhD    +421-2-5477-2800 ext 254    barbara.ukropcova@savba.sk   
Sub-Investigator: Jozef Ukropec, PhD         
Sub-Investigator: Michaela Jakubova, MD         
Principal Investigator: Barbara Ukropcova, MD, PhD         
Univeristy Hospital in Bratislava Recruiting
Bratislava, Slovakia, 81369
Contact: Boris Krahulec, MD, PhD       boris.krahulec@sm.unb.sk   
Principal Investigator: Boris Krahulec, MD, PhD         
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
  More Information

No publications provided

Responsible Party: Jozef Ukropec, PhD, Slovak Academy of Sciences
ClinicalTrials.gov Identifier: NCT02011100     History of Changes
Other Study ID Numbers: CarnoDMCVD
Study First Received: December 5, 2013
Last Updated: December 12, 2013
Health Authority: Slovak Republic: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014