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Genetic Physiopathology and Evolution of Type 2 Diabetes (GENFIEV)

This study has been completed.
Sponsor:
Collaborators:
Italian Society of Diabetology
Eli Lilly and Company
Information provided by:
University of Pisa
ClinicalTrials.gov Identifier:
NCT00879801
First received: April 9, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition
Pre-Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Genetic, Biochemical and Clinical Determinants of Type 2 Diabetes Progression in Subjects at High Risk

Resource links provided by NLM:


Further study details as provided by University of Pisa:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Serum and plasma sample, DNA


Enrollment: 1017
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with IGR
Subjects at high risk of diabetes, such as those with impaired glucose regulation (IFG and or IGT)

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).

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879801

Locations
Italy
Department of Endocrinology and Metabolism, University of Pisa
Pisa, Italy
Sponsors and Collaborators
University of Pisa
Italian Society of Diabetology
Eli Lilly and Company
  More Information

Additional Information:
No publications provided by University of Pisa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FoRiSID, Research Foundation of the Italian Society of Diabetology
ClinicalTrials.gov Identifier: NCT00879801     History of Changes
Other Study ID Numbers: GENFIEV
Study First Received: April 9, 2009
Last Updated: April 9, 2009
Health Authority: Italy: National Institute of Health

Keywords provided by University of Pisa:
prevention of diabetes
susceptibility genes
type 2 diabetes
insulin resistance
beta-cell funtion

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

ClinicalTrials.gov processed this record on November 27, 2014