Gene Expression Profiling and Bioinformatic Analysis Identifying Genes and Biochemical Pathways in Type 2 Diabetes
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | June 11, 2008 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00143013 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gene Expression Profiling and Bioinformatic Analysis Identifying Genes and Biochemical Pathways in Type 2 Diabetes | ||||
| Official Title ICMJE | Gene Expression Profiling by DNA Chips and Subsequent Bioinformatic Analysis for Identification of Genes and Biochemical Pathways Associated With Type 2 Diabetes | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Of diabetic subjects:
Of nondiabetic subjects:
Exclusion Criteria: Of diabetic subjects:
Of nondiabetic subjects:
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| Gender | Both | ||||
| Ages | 30 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00143013 | ||||
| Other Study ID Numbers ICMJE | 002 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Odense University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Odense University Hospital | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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