Type 2 DiabetesMIKRODIABNCT02231736
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)
An observational study of Type 2 Diabetes and Cancer, run by University of Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Type 2 Diabetes, Cancer
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- May 2014to Feb 2015
- Phase
- Observational
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetes patients, female,
Who may be able to join
- Type 2 Diabetes (T2DM)
- Sex: female
- Age: > 30years
- Medication: oral anti-diabetics and/or Insulin therapy
- Constant nutritional behavior, constant physical activity, constant weight for the last 4 weeks
- Non-smoking for at least 1 year
Who cannot join
- Patients with type 1 DM
- Age: < 30years
- Pregnant or lactating women
- Participation in another clinical trial
- Change of medication in regard to metabolic parameters within the last 4 weeks
- Significant cardiovascular damage with NYHA > III
Show all 13Show fewer
- Liver disease with three-times higher transaminase values
- Chronic kidney disease with serum creatinine > 2 mg/dl
- Dialysis
- HIV positive
- History of chronic alcohol abuse in the last two years
- History of cancer, stroke, organ transplantation
- Male
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna, 1090
Karl-Heinz Wagner, PhD, 004314277 ext. 54930, Karl-Heinz.wagner@univie.ac.at
Annemarie Grindel, 004314277 ext. 54901, annemarie.grindel@univie.ac.at
About this study
Official title: Incidence of Chromosomal Damage in Type 2 Diabetes Patients
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients
- Conditions
- Type 2 Diabetes, Cancer
- Keywords
- Type 2 Diabetes, Chromosomal damage, Micronuclei, DNA damage, HbA1c, Comet Assay, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes, HbA1c>7.5 | Not described | |
| Type 2 diabetes, HbA1c<7.5 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of HbA1c influences micronuclei formation in binucleated cells
In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c<7.5%) and a high (HbA1c>7.5%) glycemic group
Measured: Baseline
Secondary outcomes (1)
Type 2 diabetes duration of the subjects influences chromosomal damage
The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl-Heinz Wagner, University of Vienna
- Investigators
- Karl-Heinz Wagner, PhD, Principal investigator, UNIVIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231736
- Sponsor's protocol ID
- UNIVIE-549-1
- Acronym
- MIKRODIAB
- Status last verified
- Sep 2014
- First submitted
- 22 Jul 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Milic M, Ceppi M, Bruzzone M, Azqueta A, Brunborg G, Godschalk R, Koppen G, Langie S, Moller P, Teixeira JP, Alija A, Anderson D, Andrade V, Andreoli C, Asllani F, Bangkoglu EE, Barancokova M, Basaran N, Boutet-Robinet E, Buschini A, Cavallo D, Costa Pereira C, Costa C, Costa S, Da Silva J, Del Bo' C, Dimitrijevic Sreckovic V, Djelic N, Dobrzynska M, Durackova Z, Dvorakova M, Gajski G, Galati S, Garcia Lima O, Giovannelli L, Goroshinskaya IA, Grindel A, Gutzkow KB, Hernandez A, Hernandez C, Holven KB, Ibero-Baraibar I, Ottestad I, Kadioglu E, Kazimirova A, Kuznetsova E, Ladeira C, Laffon B, Lamonaca P, Lebailly P, Louro H, Mandina Cardoso T, Marcon F, Marcos R, Moretti M, Moretti S, Najafzadeh M, Nemeth Z, Neri M, Novotna B, Orlow I, Paduchova Z, Pastor S, Perdry H, Spremo-Potparevic B, Ramadhani D, Riso P, Rohr P, Rojas E, Rossner P, Safar A, Sardas S, Silva MJ, Sirota N, Smolkova B, Staruchova M, Stetina R, Stopper H, Surikova EI, Ulven SM, Ursini CL, Valdiglesias V, Valverde M, Vodicka P, Volkovova K, Wagner KH, Zivkovic L, Dusinska M, Collins AR, Bonassi S. The hCOMET project: International database comparison of results with the comet assay in human biomonitoring. Baseline frequency of DNA damage and effect of main confounders. Mutat Res Rev Mutat Res. 2021 Jan-Jun;787:108371. doi: 10.1016/j.mrrev.2021.108371. Epub 2021 Feb 6.
PubMed 34083035
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Chromosomal Damage in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT02231736
- Acronym / sponsor ID
- MIKRODIAB / UNIVIE-549-1
- Conditions
- Type 2 Diabetes, Cancer
- Keywords
- Type 2 Diabetes, Chromosomal damage, Micronuclei, DNA damage, HbA1c, Comet Assay, Glycemic control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 4 Sep 2014 (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.
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes, HbA1c>7.5 | – | – |
| Type 2 diabetes, HbA1c<7.5 | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes patients, female,
Key inclusion criteria (6 listed)
- Type 2 Diabetes (T2DM)
- Sex: female
- Age: > 30years
- Medication: oral anti-diabetics and/or Insulin therapy
- Constant nutritional behavior, constant physical activity, constant weight for the last 4 weeks
Key exclusion criteria (13 listed)
- Patients with type 1 DM
- Age: < 30years
- Pregnant or lactating women
- Participation in another clinical trial
- Change of medication in regard to metabolic parameters within the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The quality of HbA1c influences micronuclei formation in binucleated cells
Time frame: Baseline
In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c<7.5%) and a high (HbA1c>7.5%) glycemic group
1 secondary outcome
Type 2 diabetes duration of the subjects influences chromosomal damage
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- Derived from this study: PubMed 34083035Milic M, Ceppi M, Bruzzone M, Azqueta A, Brunborg G, Godschalk R, Koppen G, Langie S, Moller P, Teixeira JP, Alija A, Anderson D, Andrade V, Andreoli C, Asllani F, Bangkoglu EE, Barancokova M, Basaran N, Boutet-Robinet E, Buschini A, Cavallo D, Costa Pereira C, Costa C, Costa S, Da Silva J, Del Bo' C, Dimitrijevic Sreckovic V, Djelic N, Dobrzynska M, Durackova Z, Dvorakova M, Gajski G, Galati S, Garcia Lima O, Giovannelli L, Goroshinskaya IA, Grindel A, Gutzkow KB, Hernandez A, Hernandez C, Holven KB, Ibero-Baraibar I, Ottestad I, Kadioglu E, Kazimirova A, Kuznetsova E, Ladeira C, Laffon B, Lamonaca P, Lebailly P, Louro H, Mandina Cardoso T, Marcon F, Marcos R, Moretti M, Moretti S, Najafzadeh M, Nemeth Z, Neri M, Novotna B, Orlow I, Paduchova Z, Pastor S, Perdry H, Spremo-Potparevic B, Ramadhani D, Riso P, Rohr P, Rojas E, Rossner P, Safar A, Sardas S, Silva MJ, Sirota N, Smolkova B, Staruchova M, Stetina R, Stopper H, Surikova EI, Ulven SM, Ursini CL, Valdiglesias V, Valverde M, Vodicka P, Volkovova K, Wagner KH, Zivkovic L, Dusinska M, Collins AR, Bonassi S. The hCOMET project: International database comparison of results with the comet assay in human biomonitoring. Baseline frequency of DNA damage and effect of main confounders. Mutat Res Rev Mutat Res. 2021 Jan-Jun;787:108371. doi: 10.1016/j.mrrev.2021.108371. Epub 2021 Feb 6.
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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.
Karl-Heinz Wagner, PhD principal investigator
UNIVIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Cancer, run by University of Vienna at 1 site in Austria.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Heinz Wagner, PhD (00431427754930, Karl-Heinz.wagner@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of HbA1c influences micronuclei formation in binucleated cells (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231736, which also lists 1 linked publication.
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 4 Sep 2014.