Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

NCT ID: NCT02231736

Last Updated: 2014-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Brief Summary

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The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients

Detailed Description

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Conditions

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Type 2 Diabetes Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 2 diabetes, HbA1c>7.5

No interventions assigned to this group

Type 2 diabetes, HbA1c<7.5

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Karl-Heinz Wagner

Director Research Platform Active Ageing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl-Heinz Wagner, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIVIE

Locations

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University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Karl-Heinz Wagner, PhD

Role: CONTACT

00431427754930

Annemarie Grindel

Role: CONTACT

00431427754901

Facility Contacts

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Karl-Heinz Wagner, PhD

Role: primary

004314277 ext. 54930

Annemarie Grindel

Role: backup

004314277 ext. 54901

References

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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.

Reference Type DERIVED
PMID: 34083035 (View on PubMed)

Other Identifiers

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UNIVIE-549-1

Identifier Type: -

Identifier Source: org_study_id

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