Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

Cancer Clinical Trial

— MIKRODIAB  

Official title:

Incidence of Chromosomal Damage in Type 2 Diabetes Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02231736
• Other study ID #: UNIVIE-549-1
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2014
• Last updated: September 1, 2014
• Start date: May 2014

Study information

• Verified date: September 2014
• Source: University of Vienna
• Contact: Karl-Heinz Wagner, PhD
• Phone: 00431427754930
• Email: Karl-Heinz.wagner[@]univie.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cancer
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of HbA1c influences micronuclei formation in binucleated cells	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	Baseline	No
Secondary	Type 2 diabetes duration of the subjects influences chromosomal damage	The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.	Baseline	No