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CompletedNCT00879801GENFIEVUpdated Apr 10, 2009

Genetic Physiopathology and Evolution of Type 2 Diabetes

An observational study in Pre-Diabetes, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-04-10.

Sponsored by University of Pisa · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,017
Ages
30 Years to 65 Years
Sex
All
01

Study 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 to type 2 diabetes;
  2. To identify subjects at risk; and
  3. To assess the physiopathologic mechanisms responsible for the conversion.

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:

  1. To clarify the physiological mechanisms responsible for IGR;
  2. To identify the biochemical and beta-cell auto-immune parameters present in IGR;
  3. Identify genetic markers.

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.

Read the 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:

  • the pathophysiologic mechanisms responsible for the disorders of impaired glucose regulation (IGR). In particular we will evaluate insulin action and insulin secretion as a function of the degree of glucose tolerance by analyzing these parameters in normal subjects as well as in IFG/NGT, NFG/IGT, and IFG/IGT individuals;
  • the biochemical markers associated with the disorders of impaired glucose regulation (IGR). In particular we will evaluate several biochemical parameters (lipid profile, coagulative profile, microlbuminuria, free-fatty acids, PAI-1, fibrinogen, creatinine, uric acid, HbA1c);
  • the cardiovascular risk profile associated with the disorders of impaired glucose regulation (IGR). In particular, the relevant biochemical parameters will be integrated with measurements of arterial blood pressure as well as ECG recording;
  • the genetic markers associated with the disorders of impaired glucose regulation (IGR). In particular subjects will be screened for HHEX, IGF2,BP2 CDKAL1,TCF2L7, CDKN2A/B,WFS1;
  • the impact of environmental factors on the disorders of impaired glucose regulation (IGR).

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).

02

Conditions studied

  • Pre-Diabetes

Keywords

  • prevention of diabetes
  • susceptibility genes
  • type 2 diabetes
  • insulin resistance
  • beta-cell funtion
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,017 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects will be recruited from outpatients diabetic units located in different areas of Italy.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,017 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Subjects with IGR

    Subjects at high risk of diabetes, such as those with impaired glucose regulation (IFG and or IGT)

06

What researchers measure

Primary outcomes

  1. The rate of conversion to diabetes of IGR subjects carrier of type 2 diabetes susceptibility genes

    Time frame: December 2009

07

Study locations

1 site
  • Department of Endocrinology and Metabolism, University of Pisa
    Pisa, Italy
08

References and documents

Publications

  • Bianchi C, Miccoli R, Trombetta M, Giorgino F, Frontoni S, Faloia E, Marchesini G, Dolci MA, Cavalot F, Cavallo G, Leonetti F, Bonadonna RC, Del Prato S; GENFIEV Investigators. Elevated 1-hour postload plasma glucose levels identify subjects with normal glucose tolerance but impaired beta-cell function, insulin resistance, and worse cardiovascular risk profile: the GENFIEV study. J Clin Endocrinol Metab. 2013 May;98(5):2100-5. doi: 10.1210/jc.2012-3971. Epub 2013 Mar 28. PubMed 23539736 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00879801
Lead sponsor
University of Pisa
Collaborators
Italian Society of Diabetology, Eli Lilly and Company
First posted
Apr 10, 2009
Start date
Jan 2003
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Apr 10, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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