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Trial record 24 of 7637 for:    Type 2 Diabetes

Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB) (MIKRODIAB)

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ClinicalTrials.gov Identifier: NCT02231736
Recruitment Status : Unknown
Verified September 2014 by Karl-Heinz Wagner, University of Vienna.
Recruitment status was:  Recruiting
First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
Karl-Heinz Wagner, 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

Condition or disease
Type 2 Diabetes Cancer

Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Incidence of Chromosomal Damage in Type 2 Diabetes Patients
Study Start Date : May 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Type 2 diabetes, HbA1c>7.5
Type 2 diabetes, HbA1c<7.5

Primary Outcome Measures :
  1. The quality of HbA1c influences micronuclei formation in binucleated cells [ Time Frame: 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 :
  1. Type 2 diabetes duration of the subjects influences chromosomal damage [ Time Frame: Baseline ]
    The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 Diabetes patients, female,

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231736

Contact: Karl-Heinz Wagner, PhD 00431427754930 Karl-Heinz.wagner@univie.ac.at
Contact: Annemarie Grindel 00431427754901 annemarie.grindel@univie.ac.at

University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Karl-Heinz Wagner, PhD    004314277 ext 54930    Karl-Heinz.wagner@univie.ac.at   
Contact: Annemarie Grindel    004314277 ext 54901    annemarie.grindel@univie.ac.at   
Sub-Investigator: Helmuth Brath, MD         
Sponsors and Collaborators
University of Vienna
Principal Investigator: Karl-Heinz Wagner, PhD UNIVIE

Responsible Party: Karl-Heinz Wagner, Director Research Platform Active Ageing, University of Vienna
ClinicalTrials.gov Identifier: NCT02231736     History of Changes
Other Study ID Numbers: UNIVIE-549-1
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Keywords provided by Karl-Heinz Wagner, University of Vienna:
Type 2 Diabetes
Chromosomal damage
DNA damage
Comet Assay
Glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases