Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease Clinical Trial

— Carnorisk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011100
• Other study ID #: CarnoDMCVD
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: April 14, 2018
• Start date: December 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Slovak Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Metabolic Diseases
• Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Intervention

Dietary Supplement:
• Carnosine

Locations

Country	Name	City	State
Slovakia	Institute of Experimental Endocrinology Slovak Academy of Sciences	Bratislava
Slovakia	Univeristy Hospital in Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Jozef Ukropec

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	oxidative stress	AGEs and lipid peroxidation products	within one year
Primary	chronic systemic inflammation	circulating hsCRP	one year
Secondary	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