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

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ClinicalTrials.gov Identifier: NCT00143013
Recruitment Status : Unknown
Verified June 2008 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : September 2, 2005
Last Update Posted : June 12, 2008
Sponsor:
Information provided by:
Odense University Hospital

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
Type 2 Diabetes

Study Type : Observational
Estimated 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 : October 2004
Study Completion Date : April 2007

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143013


Contacts
Contact: Vibe Skov, PhD vibe.skov@ouh.regionsyddanmark.dk

Locations
Denmark
Department of Clinical Biochemistry and Genetics, KKA Recruiting
Odense C, Funen, Denmark, 5000
Contact: Vibe Skov, MSc    +45 6541 2837    vibe.skov@ouh.fyns-amt.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Vibe Skov, MSc Odense University Hospital

ClinicalTrials.gov Identifier: NCT00143013     History of Changes
Other Study ID Numbers: 002
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

Keywords provided by Odense University Hospital:
type 2 diabetes
microarray
skeletal muscle
bioinformatics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases