Status:
COMPLETED
Genetic Physiopathology and Evolution of Type 2 Diabetes
Lead Sponsor:
University of Pisa
Collaborating Sponsors:
Italian Society of Diabetology
Eli Lilly and Company
Conditions:
Pre-Diabetes
Eligibility:
All Genders
30-65 years
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: 1. An estimate of the rate of conversion ...
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 a...
Eligibility Criteria
Inclusion
- Each consecutive subject referred to a diabetes clinic for a diagnostic OGTT meeting the above criteria will be assessed as a potential candidate for the study till a total recruitment of 75 individuals will be reached.
- The OGTT will be performed after an overnight fast as described below.
- Individuals with IGT (FPG value of \< 7.0 mmol/l, and 2-h PG \> 7.8 and \< 11.1 mmol/l), IFG (FPG \> 6.1 and \< 7.0 mmol/l, and 2-h PG value of \< 11.1 mmol/l).
- Subjects who had both IFG and IGT will included as well.
- Subjects with normal glucose tolerance (FPG \<6.1 and 2-h PG \<7.8 mmol/l) will be also recruited as controls
Exclusion
- Use of drugs known to interfere with glucose metabolism (corticosteroids, beta-blockers, etc)
- Pregnant women, women who are breast feeding
- Active arterial disease (unstable angina, myocardial infarction, cerebrovascular accident, etc) within 3 months of trial entry
- History of malignancy
- Uncontrolled hypertension or hypothyroidism; history of alcohol, or drug abuse, or both
- Active liver disease
- Subjects tacking cyclic hormone replacement therapy
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1017 Patients enrolled
Trial Details
Trial ID
NCT00879801
Start Date
January 1 2003
End Date
December 1 2008
Last Update
April 10 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Endocrinology and Metabolism, University of Pisa
Pisa, Italy