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

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	September 25, 2008
Start Date ^ICMJE	May 2008
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Genetic Variants and Phenotypic Characteristics of Patients With T2DM
Official Title ^ICMJE	Genetic Variants and Phenotypic Characteristics of Patients With T2DM
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Whole blood
Sampling Method	Non-Probability Sample
Study Population	Diabetic Patients from Dept. of Endocrinology, Odense University Hospital Non-diabetic volunteers found from advertising at Odense University Hospital
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Type 2 Diabetic Patients 2 Non-diabetic individuals
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	2000
Estimated Completion Date	April 2011
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Type 2 Diabetes Mellitus > 18 years and
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00760292
Other Study ID Numbers ^ICMJE	034
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Odense University Hospital
Collaborators ^ICMJE	Danish PhD School of Molecular Metabolism University of Southern Denmark
Investigators ^ICMJE	Not Provided
Information Provided By	Odense University Hospital
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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