Effect of Carnosine on Diabetes and Cardiovascular Risk Factors (Carnorisk)
Primary Purpose
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Carnosine
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
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.
Sites / Locations
- Univeristy Hospital in Bratislava
- Institute of Experimental Endocrinology Slovak Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CARNOSINE
placebo
Arm Description
3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)
3 months placebo intake - taken twice a day (1-0-1)
Outcomes
Primary Outcome Measures
oxidative stress
AGEs and lipid peroxidation products
chronic systemic inflammation
circulating hsCRP
Secondary Outcome Measures
level of glucose intolerance
detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02011100
Brief Title
Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
Acronym
Carnorisk
Official Title
Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jozef Ukropec
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CARNOSINE
Arm Type
Experimental
Arm Description
3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
3 months placebo intake - taken twice a day (1-0-1)
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnosine
Primary Outcome Measure Information:
Title
oxidative stress
Description
AGEs and lipid peroxidation products
Time Frame
within one year
Title
chronic systemic inflammation
Description
circulating hsCRP
Time Frame
one year
Secondary Outcome Measure Information:
Title
level of glucose intolerance
Description
detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR
Time Frame
within 10 months
Other Pre-specified Outcome Measures:
Title
muscle carnosine content
Description
assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal.
Time Frame
within 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozef Ukropec, PhD
Organizational Affiliation
Institute of experimental endocrinology SAS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Ukropcova, MD, PhD
Organizational Affiliation
Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SAS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Boris Krahulec, MD, PhD
Organizational Affiliation
University Hospital in Bratislava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbora deCourten, MD, MPH, PhD, FRACP
Organizational Affiliation
Monash University
Official's Role
Study Chair
Facility Information:
Facility Name
Univeristy Hospital in Bratislava
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Institute of Experimental Endocrinology Slovak Academy of Sciences
City
Bratislava
ZIP/Postal Code
83306
Country
Slovakia
12. IPD Sharing Statement
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Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
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