Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Type 2 Diabetes Mellitus Clinical Trial

— GenVarT2DM  

Official title:

Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00760292
• Other study ID #: 034
• Status: Active, not recruiting
• Phase: N/A
• First received: September 25, 2008
• Last updated: September 25, 2008
• Start date: May 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: April 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• > 18 years and

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology, Odense University Hospital	Odense	Funen

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Danish PhD schools of Molecular Metabolism and Endocrinology, University of Southern Denmark

Country where clinical trial is conducted

Denmark,