Genetic Physiopathology and Evolution of Type 2 Diabetes (GENFIEV)
Tracking Information | |
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First Received Date ICMJE | April 9, 2009 |
Last Updated Date | April 9, 2009 |
Start Date ICMJE | January 2003 |
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
The rate of conversion to diabetes of IGR subjects carrier of type 2 diabetes susceptibility genes [ Time Frame: December 2009 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Genetic Physiopathology and Evolution of Type 2 Diabetes |
Official Title ICMJE | Evaluation of Genetic, Biochemical and Clinical Determinants of Type 2 Diabetes Progression in Subjects at High Risk |
Brief Summary | There are few longitudinal studies in the Caucasian population and even less in the Italian population in subjects with impaired glucose regulation to allow:
In order to set up a longitudinal study capable of defining the above parameters it is mandatory that the physiological, biochemical, and, genetic markers specific for IGR are identified. The goals of the present research proposal are:
The subjects who will be identified will add up to other 900 individuals who will be recruited as part of a follow-up program sponsored by the Italian Society of Diabetes, specifically designed to assess conversion rate to diabetes. |
Detailed Description | The main goal of the present research program is to recruit about 600 new subjects with IGR to be added to the 900 subjects which are collected as part of the GENFIEV project which has been designed as a 6-yr follow-up study to ascertain the rate of conversion to type 2 diabetes in the Italian population. In particular the goal of the present research program will be to determine in a sample of the Italian population at greater risk for type 2 diabetes than the general population:
Finally, we will endeavour to assess the cellular pathways that may be affected by metabolic alterations typically occurring in concomitance with the disorders of impaired glucose regulation (IGR). |
Study Type ICMJE | Observational |
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
Biospecimen | Retention: Samples With DNA Description: Serum and plasma sample, DNA |
Sampling Method | Probability Sample |
Study Population | Subjects will be recruited from outpatients diabetic units located in different areas of Italy. |
Condition ICMJE | Pre-Diabetes |
Intervention ICMJE | |
Study Group/Cohort (s) | Subjects with IGR
Subjects at high risk of diabetes, such as those with impaired glucose regulation (IFG and or IGT) |
Publications * | |
* 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 | Completed |
Enrollment ICMJE | 1017 |
Completion Date | December 2008 |
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 30 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | Italy |
Administrative Information | |
NCT Number ICMJE | NCT00879801 |
Other Study ID Numbers ICMJE | GENFIEV |
Has Data Monitoring Committee | Yes |
Responsible Party | FoRiSID, Research Foundation of the Italian Society of Diabetology |
Study Sponsor ICMJE | University of Pisa |
Collaborators ICMJE |
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Investigators ICMJE | |
Information Provided By | University of Pisa |
Verification Date | April 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |