Left Ventricular DYsfunction in DiAbetes

NCT ID: NCT01971125

Last Updated: 2023-09-25

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

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Recruitment Status

COMPLETED

Total Enrollment

970 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Heart Diseases Left Ventricular Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Care Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Comaschi, M.D.

Role: STUDY_CHAIR

Andrea di Lenarda, M.D.

Role: STUDY_CHAIR

Locations

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Casa di Cura Pineta del Carso

Duino-Aurisina, Friuli Venezia Giulia, Italy

Site Status

A.O.- Univ. Ospedali Riuniti

Trieste, Friuli Venezia Giulia, Italy

Site Status

Azienda Servizi Sanitari N°1 Triestina

Trieste, Friuli Venezia Giulia, Italy

Site Status

Presidio Ospedaliero

Sanremo, Liguria, Italy

Site Status

Ospedali Riuniti

Bergamo, Lombardy, Italy

Site Status

Spedali Civili

Brescia, Lombardy, Italy

Site Status

Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

Ospedale San Paolo

Milan, Lombardy, Italy

Site Status

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Site Status

IRCCS Policlinico Multimedica

Sesto San Giovanni, Lombardy, Italy

Site Status

Ospedale Maggiore

Chieri, Piedmont, Italy

Site Status

A.O. Santa Croce e Carle

Cuneo, Piedmont, Italy

Site Status

Ospedale Mauriziano

Turin, Piedmont, Italy

Site Status

Ospedale Civile

Mirano, Veneto, Italy

Site Status

Countries

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Italy

References

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King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.

Reference Type BACKGROUND
PMID: 9727886 (View on PubMed)

Cioffi G, Giorda CB, Chinali M, Di Lenarda A, Faggiano P, Lucci D, Maggioni AP, Masson S, Mureddu GF, Tarantini L, Velussi M, Comaschi M; DYDA Investigators. Analysis of midwall shortening reveals high prevalence of left ventricular myocardial dysfunction in patients with diabetes mellitus: the DYDA study. Eur J Prev Cardiol. 2012 Oct;19(5):935-43. doi: 10.1177/1741826711417759. Epub 2011 Jul 28.

Reference Type BACKGROUND
PMID: 21798988 (View on PubMed)

Cioffi G, Faggiano P, Lucci D, Di Lenarda A, Mureddu GF, Tarantini L, Verdecchia P, Comaschi M, Giorda CB, Velussi M, Chinali M, Latini R, Masson S, De Simone G; DYDA Investigators. Inappropriately high left ventricular mass in patients with type 2 diabetes mellitus and no overt cardiac disease. The DYDA study. J Hypertens. 2011 Oct;29(10):1994-2003. doi: 10.1097/HJH.0b013e32834acc6d.

Reference Type BACKGROUND
PMID: 21881524 (View on PubMed)

Cioffi G, Faggiano P, Lucci D, Maggioni AP, Manicardi V, Travaglini A, Girfoglio D, Masson S, Giorda CB, Velussi M, Di Lenarda A, Verdecchia P, Comaschi M. Left ventricular dysfunction and outcome at two-year follow-up in patients with type 2 diabetes: The DYDA study. Diabetes Res Clin Pract. 2013 Aug;101(2):236-42. doi: 10.1016/j.diabres.2013.05.010. Epub 2013 Jun 24.

Reference Type BACKGROUND
PMID: 23806478 (View on PubMed)

Masson S, Latini R, Cioffi G, Urso R, Vago T, Lucci D, Mureddu GF, Tarantini L, Faggiano P, Girfoglio D, Velussi M, Maggioni AP, Giorda CB, Comaschi M; DYDA Investigators. Cardiovascular biomarkers, cardiac dysfunction, and outcomes in patients with type 2 diabetes: a prospective, multicenter study. Diabetes Care. 2013 Sep;36(9):e137-8. doi: 10.2337/dc13-0836. No abstract available.

Reference Type BACKGROUND
PMID: 23970719 (View on PubMed)

Giorda CB, Cioffi G, de Simone G, Di Lenarda A, Faggiano P, Latini R, Lucci D, Maggioni AP, Tarantini L, Velussi M, Verdecchia P, Comaschi M; DYDA Investigators. Predictors of early-stage left ventricular dysfunction in type 2 diabetes: results of DYDA study. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):415-23. doi: 10.1177/1741826710389402. Epub 2011 Feb 22.

Reference Type RESULT
PMID: 21450640 (View on PubMed)

Related Links

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Other Identifiers

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G 107

Identifier Type: -

Identifier Source: org_study_id

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