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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00143013
First received: September 1, 2005
Last updated: June 11, 2008
Last verified: June 2008

September 1, 2005
June 11, 2008
October 2004
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Complete list of historical versions of study NCT00143013 on ClinicalTrials.gov Archive Site
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Gene Expression Profiling and Bioinformatic Analysis Identifying Genes and Biochemical Pathways in Type 2 Diabetes
Gene Expression Profiling by DNA Chips and Subsequent Bioinformatic Analysis for Identification of Genes and Biochemical Pathways Associated With Type 2 Diabetes

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.

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Observational
Time Perspective: Prospective
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Type 2 Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2007
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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
Both
30 Years to 65 Years
Yes
Contact: Vibe Skov, PhD vibe.skov@ouh.regionsyddanmark.dk
Denmark
 
NCT00143013
002
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Odense University Hospital
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Principal Investigator: Vibe Skov, MSc Odense University Hospital
Odense University Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP