Metabolic Diseases, Type 2 Diabetes, Cardiovascular DiseaseCarnoriskNCT02011100
Effect of Carnosine on Diabetes and Cardiovascular Risk Factors
A study testing Carnosine in people with Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease, run by Jozef Ukropec at 2 sites in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- Carnosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesSlovakia
- Study dates
- Dec 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI (28-38 kg.m-2);
- waist circumference >94 cm;
- % body fat 30%
- fasting glycemia < 7 mmol/l
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
Univeristy Hospital in Bratislava
Bratislava, 81369
Institute of Experimental Endocrinology Slovak Academy of Sciences
Bratislava, 83306
About this study
Official title: Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
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.
- Being tested
- Carnosine
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarnosineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| CARNOSINE | Experimental | 3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1) Receives: Dietary Supplement: Carnosine |
| placebo | Placebo comparator | 3 months placebo intake - taken twice a day (1-0-1) Receives: Dietary Supplement: Carnosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress
AGEs and lipid peroxidation products
Measured: within one year
chronic systemic inflammation
circulating hsCRP
Measured: one year
Secondary outcomes (1)
level of glucose intolerance
detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR
Measured: within 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Diseases, Type 2 Diabetes, Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jozef Ukropec
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jozef Ukropec, Slovak Academy of Sciences
- Investigators
- Jozef Ukropec, PhD, Principal investigator, Institute of experimental endocrinology SASBarbara Ukropcova, MD, PhD, Study director, Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SASBoris Krahulec, MD, PhD, Study chair, University Hospital in BratislavaBarbora deCourten, MD, MPH, PhD, FRACP, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011100
- Sponsor's protocol ID
- CarnoDMCVD
- Acronym
- Carnorisk
- Status last verified
- Apr 2018
- First submitted
- 5 Dec 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02011100
- Acronym / sponsor ID
- Carnorisk / CarnoDMCVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jozef UkropecOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARNOSINE | Experimental | Dietary Supplement: Carnosine3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1) |
| placebo | Placebo comparator | Dietary Supplement: Carnosine3 months placebo intake - taken twice a day (1-0-1) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI (28-38 kg.m-2);
- waist circumference >94 cm;
- % body fat 30%
- fasting glycemia < 7 mmol/l
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carnosine | Dietary supplement | CARNOSINE, placebo |
Primary outcome
oxidative stress
Time frame: within one year
AGEs and lipid peroxidation products
chronic systemic inflammation
Time frame: one year
circulating hsCRP
1 secondary outcome
level of glucose intolerance
Time frame: within 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jozef Ukropec, PhD principal investigator
Institute of experimental endocrinology SAS
Barbara Ukropcova, MD, PhD study director
Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SAS
Boris Krahulec, MD, PhD study chair
University Hospital in Bratislava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carnosine in people with Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease, run by Jozef Ukropec at 2 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidative stress (time frame: within one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.