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NCT00520962 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00520962
Other study ID # 199402-1369/516
Secondary ID
Status Completed
Phase N/A
First received August 24, 2007
Last updated August 24, 2007
Start date June 1997
Est. completion date May 2006

Study information
Verified date August 2007
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1997
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Medicine Division, Diabetology, Endocrinology and Metabolic Disease Unit, IRCCS San Raffaele Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

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