Clinical trial NCT00143013: Gene Expression Profiling and Bioinformatic Analysis Identifying Genes and Biochemical Pathways in Type 2 Diabetes
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
microarray
skeletal muscle
bioinformatics
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Clinical Biochemistry and Genetics, KKA
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Vibe Skov, MSc
role: PRINCIPAL_INVESTIGATOR
References: