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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
Danish PhD schools of Molecular Metabolism and Endocrinology
University of Southern Denmark
Information provided by:
Odense University Hospital Identifier:
First received: September 25, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

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.

Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Further study details as provided by Odense University Hospital:

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 2000
Study Start Date: May 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Type 2 Diabetic Patients
Non-diabetic individuals


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

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • > 18 years and
  Contacts and Locations
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Please refer to this study by its identifier: NCT00760292

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
  More Information Identifier: NCT00760292     History of Changes
Other Study ID Numbers: 034
Study First Received: September 25, 2008
Last Updated: September 25, 2008

Keywords provided by Odense University Hospital:
Type 2 Diabetes Mellitus
Genetic Variants
DNA microarray

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 23, 2017