Clinical trial NCT02231736: Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)
Official title: Incidence of Chromosomal Damage in Type 2 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Cancer
Keywords: Type 2 Diabetes
Chromosomal damage
Micronuclei
DNA damage
HbA1c
Comet Assay
Glycemic control
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 130
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetes patients, female,

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


Eligibility criteria: 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

Primary outcomes:
measure: The quality of HbA1c influences micronuclei formation in binucleated cells
timeFrame: Baseline
Secondary outcomes:
measure: Type 2 diabetes duration of the subjects influences chromosomal damage
timeFrame: Baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
affiliation: UNIVIE
name: Karl-Heinz Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.