Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

Incidence of Chromosomal Damage in Type 2 Diabetes Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02231736

Acronym

MIKRODIAB

Enrollment

130

Registered

2014-09-04

Start date

2014-05-31

Completion date

Unknown

Last updated

2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Type 2 Diabetes

Keywords

Type 2 Diabetes, Chromosomal damage, Micronuclei, DNA damage, HbA1c, Comet Assay, Glycemic control

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The quality of HbA1c influences micronuclei formation in binucleated cells	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

Secondary

Measure	Time frame	Description
Type 2 diabetes duration of the subjects influences chromosomal damage	Baseline	The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.

Countries

Austria

Contacts

Primary ContactKarl-Heinz Wagner, PhD

Karl-Heinz.wagner@univie.ac.at00431427754930

Backup ContactAnnemarie Grindel

annemarie.grindel@univie.ac.at00431427754901

Outcome results