Clinical trial NCT02011100: Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
Official title: Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2013-12-13
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: oxidative stress
timeFrame: within one year
measure: chronic systemic inflammation
timeFrame: one year
Secondary outcomes:
measure: level of glucose intolerance
timeFrame: within 10 months
Other outcomes:
measure: muscle carnosine content
timeFrame: within 9 months
Locations:
city: Bratislava
country: Slovakia
facility: Univeristy Hospital in Bratislava
city: Bratislava
country: Slovakia
facility: Institute of Experimental Endocrinology Slovak Academy of Sciences
Study officials:
affiliation: Institute of experimental endocrinology SAS
name: Jozef Ukropec, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SAS
name: Barbara Ukropcova, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital in Bratislava
name: Boris Krahulec, MD, PhD
role: STUDY_CHAIR
affiliation: Monash University
name: Barbora deCourten, MD, MPH, PhD, FRACP
role: STUDY_CHAIR
References: