Clinical trial · Observational
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)
Incidence of Chromosomal Damage in Type 2 Diabetes Patients
NCT02231736CI-TRIAL-00015536MIKRODIABunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Type 2 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Type 2 diabetes, HbA1c>7.5
- label
- Type 2 diabetes, HbA1c<7.5
Primary outcomes (1)
- measure
- The quality of HbA1c influences micronuclei formation in binucleated cells
- timeFrame
- Baseline
- description
- 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
Secondary outcomes (1)
- measure
- Type 2 diabetes duration of the subjects influences chromosomal damage
- timeFrame
- Baseline
- description
- The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMilic 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. PMID 34083035