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

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ClinicalTrials.gov Identifier: NCT00520962
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : August 27, 2007
Sponsor:
Information provided by:

Study Description
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 Design

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
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Eligibility Criteria

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 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
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