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

September 1, 2014 updated by: Karl-Heinz Wagner, University of Vienna

Incidence of Chromosomal Damage in Type 2 Diabetes Patients

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Type 2 Diabetes patients, female,

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 2 diabetes, HbA1c>7.5
Type 2 diabetes, HbA1c<7.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Investigators

  • Principal Investigator: Karl-Heinz Wagner, PhD, UNIVIE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

September 1, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 4, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVIE-549-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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