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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Denmark
  • Funen
    • Odense, Funen, Denmark, 5000
      • Dept. of Endocrinology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Type 2 Diabetes Mellitus
• > 18 years and

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark; Danish PhD schools of Molecular Metabolism and Endocrinology

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Estimate): September 26, 2008
• Last Update Submitted That Met QC Criteria: September 25, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; SNP; DNA microarray; Genetic Variants
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 034