Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

• Conditions: Type 2 Diabetes; Cancer

• Registration Number: NCT02231736
• Lead Sponsor: University of Vienna

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-22
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-01
• Last Update Submitted: 2014-09-01
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04
• Primary Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria