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NCT01971125 Clinical Trial

Left Ventricular DYsfunction in DiAbetes

Diabetes Mellitus, Type 2 Clinical Trial

— DYDA  

Official title:
Left Ventricular DYsfunction in DiAbetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01971125
Other study ID # G 107
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2006
Est. completion date November 2010

Study information
Verified date October 2013
Source Heart Care Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 970
Est. completion date November 2010
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedali Riuniti Bergamo Lombardia
Italy Spedali Civili Brescia Lombardia
Italy Ospedale Maggiore Chieri Piemonte
Italy A.O. Santa Croce e Carle Cuneo Piemonte
Italy Casa di Cura Pineta del Carso Duino - Aurisina Friuli - Venezia Giulia
Italy Ospedale San Paolo Milano Lombardia
Italy Ospedale San Raffaele Milano Lombardia
Italy Ospedale Civile Mirano Veneto
Italy Istituto Clinico Humanitas Rozzano Lombardia
Italy Presidio Ospedaliero Sanremo Liguria
Italy IRCCS Policlinico Multimedica Sesto San Giovanni Lombardia
Italy Ospedale Mauriziano Torino Piemonte
Italy A.O.- Univ. Ospedali Riuniti Trieste Friuli - Venezia Giulia
Italy Azienda Servizi Sanitari N°1 Triestina Trieste Friuli - Venezia Giulia

Sponsors (1)
Lead Sponsor Collaborator
Heart Care Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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 st — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Left Ventricular Dysfunction in patients with type II diabetes 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
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