Text Size

The Verona Newly Diagnosed Type 2 Diabetes Study (VNDS)

This study is currently recruiting participants.
Verified February 2012 by Universita di Verona
Sponsor:
Collaborators:
European Foundation for the Study of Diabetes
MIUR, Italian Ministry of Education University and Research
Information provided by (Responsible Party):
Riccardo Bonadonna, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01526720
First received: January 27, 2012
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

Type 2 diabetes mellitus is a complex disease whose clinical phenotype results from the variable combination of genetic and nongenetic factors. The aim of the present study is to investigate the network linking phenotypes and genotypes in patients with newly diagnosed type 2 diabetes mellitus. In selected cases, in which clinical evidence hints at possible monogenic basis of the disease, the genotype and the phenotype of relatives also will be assessed to elucidate further the etiology of the disease.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Verona Newly Diagnosed Type 2 Diabetes Study. Construction of a Biobank of Diabetes Related Genotypes and Phenotypes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Genetic basis of beta cell function [ Time Frame: Baseline and during the 75 g oral glucose challenge. Subjects will be followed for the duration of their stay in the Metabolic Clinical Research Center (average expected stay: 6 hours) ] [ Designated as safety issue: No ]

    Investigators genotype diabetes risk loci and relate them to two main beta cell metrics, after correction for insulin sensitivity:

    1. Derivative control of beta cell function: it is the amount of insulin secreted in response to a rate of glucose increase of 1 mmol/l per min which lasts for 1 minute;
    2. Proportional control of beta cell function: it is the stimulus-response curve linking glucose concentration (x-axis) to insulin secretion rate (y-axis) at the preselected glucose concentrations of 5.5, 8.0, 11.0, 15.0, and 20.0 mmol/liter.


Secondary Outcome Measures:
  • Genetic basis of insulin sensitivity [ Time Frame: Baseline and during the euglycemic insulin clamp. Subjects will be followed for the duration of their stay in the Metabolic Clinical Research Center (average stay: 4 hours) ] [ Designated as safety issue: No ]

    Investigators genotype diabetes risk loci and relate them, after correcting for the influence of other genetic and nongenetic modifiers, to one metric of clamp derived insulin sensitivity:

    1. M value, which quantifies whole body net glucose disposal during euglycemic hyperinsulinemia



Biospecimen Retention:   Samples With DNA

Whole blood Serum Plasma Urine


Estimated Enrollment: 1500
Study Start Date: October 2003
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A: Diabetic
Newly diagnosed type 2 diabetic patients (i.e. diagnosis made no more than 6 months before recruitment)
Group B: Relatives
Relatives of patients with potentially monogenic newly diagnosed type 2 diabetes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Group A: all patients referred to the Division of Endocrinology and Metabolic Diseases of University of Verona School of Medicine, whose diabetes has been diagnosed in the last six months, are asked to participate in this research.

Group B: Relatives of patients with potentially monogenic newly diagnosed type 2 diabetes

Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus, whose diagnosis has been made in the last six months before the first access to the Division of Endocrinology and Metabolic Diseases of University of Verona School of Medicine;
  • Relatives of patients with potentially monogenic newly diagnosed type 2 diabetes

Exclusion Criteria:

  • Age > 75 years
  • Non-Italian ancestry
  • Insulin treatment
  • Presence of anti-GAD antibodies
  • Malignancies
  • Any condition severely impairing liver and/or kidney function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526720

Contacts
Contact: Riccardo C Bonadonna, MD +39 045 8123110 riccardo.bonadonna@univr.it

Locations
Italy
Division of Endocrinology and Metabolic Diseases - University Hospital of Verona Recruiting
Verona, Italy, 37126
Sponsors and Collaborators
Universita di Verona
European Foundation for the Study of Diabetes
MIUR, Italian Ministry of Education University and Research
Investigators
Study Chair: Enzo Bonora, MD PhD Section of Endocrinology, Diabetes and Metabolism - Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata, Verona, Italy
Principal Investigator: Riccardo C Bonadonna, MD Section of Endocrinology, Diabetes and Metabolism - Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata, Verona, Italy
  More Information

No publications provided

Responsible Party: Riccardo Bonadonna, Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT01526720     History of Changes
Other Study ID Numbers: CE-955
Study First Received: January 27, 2012
Last Updated: February 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
Type 2 diabetes mellitus
Beta cell function
Insulin sensitivity
Genetics of diabetes

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

ClinicalTrials.gov processed this record on May 19, 2013