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

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00520962
First received: August 24, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 24, 2007
August 24, 2007
June 1997
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No Changes Posted
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Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk
New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)

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.

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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Diabetes Mellitus, Type 2
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  • 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
Monti LD, Lucotti PC, Setola E, Rossodivita A, Pala MG, Galluccio E, LaCanna G, Castiglioni A, Cannoletta M, Meloni C, Zavaroni I, Bosi E, Alfieri O, Piatti PM. Effects of chronic elevation of atrial natriuretic peptide and free fatty acid levels in the induction of type 2 diabetes mellitus and insulin resistance in patients with mitral valve disease. Nutr Metab Cardiovasc Dis. 2012 Jan;22(1):58-65. Epub 2010 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1997
May 2006
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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
Both
30 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00520962
199402-1369/516
Yes
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IRCCS San Raffaele
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Principal Investigator: PierMarco Piatti, MD IRCSS San Raffaele
IRCCS San Raffaele
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP