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

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. Identifier: NCT00520962
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : August 27, 2007
Information provided by:
IRCCS San Raffaele

Brief Summary:

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 or disease
Diabetes Mellitus, Type 2

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.

Study Type : Observational
Actual Enrollment : 1997 participants
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)
Study Start Date : June 1997
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00520962

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00520962     History of Changes
Other Study ID Numbers: 199402-1369/516
First Posted: August 27, 2007    Key Record Dates
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
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