Gene Expression Profiling and Bioinformatic Analysis Identifying Genes and Biochemical Pathways in Type 2 Diabetes

Sponsor

Odense University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00143013

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Type 2 diabetes is a disorder of the metabolic system that greatly affects individual health and imposes significant cost for society on health care. It is necessary to initiate research with emphasis on improvement on quality of life and reduce the serious complications as a result of type 2 diabetes.

In type 2 diabetes insulin resistance and impairment of insulin secretion by beta-cells are the major pathophysiological defects and characterized by raised plasma glucose levels. Today, little is known about gene regulation and biochemical pathways involved in the disease.

Bioinformatics and gene expression microarrays (GEM) will be applied to gain insight into the molecular pathophysiology of type 2 diabetes. The simultaneous monitoring of thousands of genes in parallel can identify novel genes and entire biochemical pathways that are dysregulated at the transcriptional level. Affymetrix Inc. chips or spotted arrays will be applied as DNA microarray tools. Bioinformatic software programs and databases will be employed as data mining tools in order to perform statistical analysis, cluster analysis and biochemical pathway analysis.

Biopsies from skeletal muscle and adipose tissue from both diabetics and nondiabetics will be applied. Changes in genes and biochemical pathways between diabetics and nondiabetics and functional relationships between adipose tissue and skeletal muscle will be investigated.

Grouping of subtypes in type 2 diabetes will be performed and a classification system will be constructed. Building a classifier may provide better and more precise diagnosis of type 2 diabetes.

Major advances in health science of type 2 diabetes thus seems to be promising and paving the way for individual treatment based on a more precise diagnosis.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Time Perspective:

Prospective

Official Title:

Gene Expression Profiling by DNA Chips and Subsequent Bioinformatic Analysis for Identification of Genes and Biochemical Pathways Associated With Type 2 Diabetes

Study Start Date :

Oct 1, 2004

Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Of diabetic subjects:

Type 2 diabetes
Age: 30-65 years
BMI: 27-35

Of nondiabetic subjects:

Age: 30-65 years
BMI: 27-35

Exclusion Criteria:

Of diabetic subjects:

Medication, which have any influence on glucose metabolism and gene expression in adipose tissue and skeletal muscle at the time of sampling of biopsies.
Disease in liver, heart, vessels or endocrine organs

Of nondiabetic subjects:

Type 2 diabetes
Relatives with type 2 diabetes
Hyperglycemia
Medication, which have any influence on glucose metabolism and gene expression in adipose tissue and skeletal muscle at the time of sampling of biopsies.
Disease in liver, heart, vessels or endocrine organs