Genetic Physiopathology and Evolution of Type 2 Diabetes

NCT00879801 | Completed DMC

• 1 other identifier: GENFIEV
• Study Type: observational
• Target: 1,017
• Locations: 1 country
• Sites: 1

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. 1.An estimate of the rate of conversion to type 2 diabetes;
2. 2.To identify subjects at risk; and
3. 3.To assess the physiopathologic mechanisms responsible for the conversion.
4. 4.To clarify the physiological mechanisms responsible for IGR;
5. 5.To identify the biochemical and beta-cell auto-immune parameters present in IGR;
6. 6.Identify genetic markers.

Conditions

Pre-Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  December 2009

Study Arms (1)

Subjects with IGR

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

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead
• Italian Society of Diabetology: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Department of Endocrinology and Metabolism, University of Pisa

Pisa, Italy

Location

Related Publications (1)

• 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.

  PMID: 23539736 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma sample, DNA

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 10, 2009
• Study Start: January 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 10, 2009

Record last verified: 2009-04

Locations

IT (1)