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

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ClinicalTrials.gov Identifier: NCT00760292
Recruitment Status : Unknown
Verified June 2008 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2008
Last Update Posted : September 26, 2008
Sponsor:
Collaborators:
Danish PhD schools of Molecular Metabolism and Endocrinology
University of Southern Denmark
Information provided by:
Odense University Hospital

Brief Summary:

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 or disease
Type 2 Diabetes Mellitus

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic Variants and Phenotypic Characteristics of Patients With T2DM
Study Start Date : May 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Type 2 Diabetic Patients
2
Non-diabetic individuals



Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00760292


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

ClinicalTrials.gov Identifier: NCT00760292     History of Changes
Other Study ID Numbers: 034
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: June 2008

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