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Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520962
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IRCCS San Raffaele
  Purpose

The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.

The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be > 30 years, both gender.


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Enrollment: 1997
Study Start Date: June 1997
Study Completion Date: May 2006
Groups/Cohorts
Case: 1,2,3
  1. First degree relatives of patients with type 2 diabetes
  2. Patients with cardiovascular disease and stroke
  3. patients with heart valve disease
Control: 4
Healthy controls

Detailed Description:
The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of endothelial function, of natriuretic peptides and free fatty acids, and inflammation before and 2 hours post-glucose load. New candidate genes will be also evaluated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fasting glucose levels <126 mg/dl
  • Age >30 years
  • Both male and female

Exclusion Criteria:

  • Type 1 diabetes
  • Known type 2 diabetes mellitus
  • Pregnancy
  • Impaired kidney and liver function
  • Previous history of malignancies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520962


Locations
Italy
Medicine Division, Diabetology, Endocrinology and Metabolic Disease Unit, IRCCS San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: PierMarco Piatti, MD IRCSS San Raffaele
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00520962     History of Changes
Other Study ID Numbers: 199402-1369/516
First Submitted: August 24, 2007
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by IRCCS San Raffaele:
cardiovascular disease
glucose intolerance
type 2 diabetes
endothelial dysfunction
inflammation
Age> 30 years, male and female
Fasting glucose below 126 mg/dl

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