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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1997 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-06-30

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

4

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

PierMarco Piatti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCSS San Raffaele

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medicine Division, Diabetology, Endocrinology and Metabolic Disease Unit, IRCCS San Raffaele

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/j.numecd.2010.04.005. Epub 2010 Aug 14.

Reference Type DERIVED

PMID: 20709514 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

199402-1369/516

Identifier Type: -

Identifier Source: org_study_id