Left Ventricular DYsfunction in DiAbetes (DYDA)

September 22, 2023 updated by: Heart Care Foundation
The purpose of this study is to evaluate the prevalence, during the enrolment, of Left Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2 without known or documented heart disease history and recognize its predictive clinical, biohumoral and with non-invasive techniques parameters.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

970

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Friuli - Venezia Giulia
      • Duino - Aurisina, Friuli - Venezia Giulia, Italy, 34011
        • Casa di Cura Pineta del Carso
      • Trieste, Friuli - Venezia Giulia, Italy, 34100
        • A.O.- Univ. Ospedali Riuniti
      • Trieste, Friuli - Venezia Giulia, Italy, 34100
        • Azienda Servizi Sanitari N°1 Triestina
    • Liguria
      • Sanremo, Liguria, Italy, 18038
        • Presidio Ospedaliero
    • Lombardia
      • Bergamo, Lombardia, Italy, 24100
        • Ospedali Riuniti
      • Brescia, Lombardia, Italy, 25100
        • Spedali Civili
      • Milano, Lombardia, Italy, 20010
        • Ospedale San Raffaele
      • Milano, Lombardia, Italy, 20100
        • Ospedale San Paolo
      • Rozzano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas
      • Sesto San Giovanni, Lombardia, Italy, 20099
        • IRCCS Policlinico Multimedica
    • Piemonte
      • Chieri, Piemonte, Italy, 10023
        • Ospedale Maggiore
      • Cuneo, Piemonte, Italy, 12100
        • A.O. Santa Croce e Carle
      • Torino, Piemonte, Italy, 10125
        • Ospedale Mauriziano
    • Veneto
      • Mirano, Veneto, Italy, 30035
        • Ospedale Civile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes mellitus type 2 without known or documented heart disease history and recognize its predictive clinical, biohumoral and with non-invasive techniques parameters.

Description

Inclusion Criteria:

  • diabetes mellitus type 2
  • absence of heart disease previously reported
  • age >45 years
  • Informed Consent

Exclusion Criteria:

  • presence of heart disease previously reported
  • diabetes type 1
  • serious systemic disease, with an expected lifetime lower than 2 years
  • no willingness to participate to the screening
  • inadequate compliance to study procedure
  • participation to other study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment

Patients with:

  • diabetes mellitus type 2
  • absence of heart disease previously reported
  • age >45 years
  • Informed Consent

Patients without:

  • presence of heart disease previously reported
  • diabetes type 1
  • serious systemic disease, with an expected lifetime lower than 2 years
  • no willingness to participate to the screening
  • inadequate compliance to study procedure
  • participation to other study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Left Ventricular Dysfunction in patients with type II diabetes
Time Frame: left ventricula dysfunction at enrollment
To evaluate the prevalence of left ventricular dysfunction (LVD), diastolic or systolic in patients with type II diabetes mellitus in the absence of clinical signs/symptoms of cardiac abnormalities To identify the predictors of LVD
left ventricula dysfunction at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

Investigators

  • Study Chair: Marco Comaschi, M.D.
  • Study Chair: Andrea di Lenarda, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimated)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G 107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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