Clinical trial NCT01971125: Left Ventricular DYsfunction in DiAbetes
Official title: Left Ventricular DYsfunction in DiAbetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Heart Diseases
Left Ventricular Dysfunction
Keywords: Diabetes Mellitus, Type 2
Heart Diseases
Left Ventricular Dysfunction
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 970
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Left Ventricular Dysfunction in patients with type II diabetes
timeFrame: left ventricula dysfunction at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Duino - Aurisina
country: Italy
facility: Casa di Cura Pineta del Carso
state: Friuli - Venezia Giulia
city: Trieste
country: Italy
facility: A.O.- Univ. Ospedali Riuniti
state: Friuli - Venezia Giulia
city: Trieste
country: Italy
facility: Azienda Servizi Sanitari N°1 Triestina
state: Friuli - Venezia Giulia
city: Sanremo
country: Italy
facility: Presidio Ospedaliero
state: Liguria
city: Bergamo
country: Italy
facility: Ospedali Riuniti
state: Lombardia
city: Brescia
country: Italy
facility: Spedali Civili
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Paolo
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Sesto San Giovanni
country: Italy
facility: IRCCS Policlinico Multimedica
state: Lombardia
city: Chieri
country: Italy
facility: Ospedale Maggiore
state: Piemonte
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle
state: Piemonte
city: Torino
country: Italy
facility: Ospedale Mauriziano
state: Piemonte
city: Mirano
country: Italy
facility: Ospedale Civile
state: Veneto
Study officials:
name: Marco Comaschi, M.D.
role: STUDY_CHAIR
name: Andrea di Lenarda, M.D.
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.
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.
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 study. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):415-23. doi: 10.1177/1741826710389402. Epub 2011 Feb 22.