GenVarT2DM: Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Sponsor

Odense University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00760292

Collaborator

Danish PhD schools of Molecular Metabolism and Endocrinology (Other), University of Southern Denmark (Other)

2,000

Enrollment

Location

Duration (Months)

57.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus

Study Design

Study Type:

Observational

Anticipated 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 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 Type 2 Diabetic Patients
2 Non-diabetic individuals

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Type 2 Diabetes Mellitus
18 years and

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00760292

Other Study ID Numbers:

First Posted:

Sep 26, 2008

Last Update Posted:

Sep 26, 2008

Last Verified:

Jun 1, 2008

Keywords provided by , ,

Type 2 Diabetes Mellitus

Genetic Variants

SNP

DNA microarray

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 26, 2008