Genetic Variants and Phenotypic Characteristics of Patients With T2DM (GenVarT2DM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danish PhD School of Molecular Metabolism
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00760292
First received: September 25, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

Background: Genetic risk-markers associated with T2DM are thoroughly studied. So far, only a few genetic variants, also termed single nucleotide polymorphisms (SNP's), have been replicated in several studies and each of them gives only limited explanation for the growing incidence of T2DM. The hypothesis of the present study is that determination of combinations of genetic variants by SNP-chip technology may improve the prediction of T2DM, complications and efficacy of treatment compared to the methods previously used including genome wide association (GWA) studies. The SNP-chip/ DNA microarray makes it possible to study several SNP's association with T2DM, one by one but also in combination.

Aims: To study whether specific genetic variants, and combinations of these, 1) are present with higher prevalence in patients with T2DM than in the normal population, 2) are associated with specific diabetes-related complications and 3) the effect of the anti-diabetic treatment.

Methods: During the next three years 1000 patients with T2DM and 1000 healthy, non-diabetic persons will be included in the study, and examined by blood samples, a questionnaire and clinical evaluation, all in one visit. Initially, we will perform DNA analyses on blood samples from 372 patients included in another clinical study from our department. Description of genetics will be done by a DNA-chip with approximately 70 SNP's, which have previously been reported to be associated with T2DM.

Results and conclusions: It is expected that the result of this project can help us predicting T2DM, diabetes-related complications and individualizing treatment to the individual patient with T2DM.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 2000
Study Start Date: May 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Type 2 Diabetic Patients
2
Non-diabetic individuals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Diabetic Patients from Dept. of Endocrinology, Odense University Hospital
  2. Non-diabetic volunteers found from advertising at Odense University Hospital
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • > 18 years and
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760292

Locations
Denmark
Dept. of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Danish PhD School of Molecular Metabolism
University of Southern Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00760292     History of Changes
Other Study ID Numbers: 034
Study First Received: September 25, 2008
Last Updated: September 25, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Type 2 Diabetes Mellitus
Genetic Variants
SNP
DNA microarray

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

ClinicalTrials.gov processed this record on October 16, 2014