DYDA: Left Ventricular DYsfunction in DiAbetes

Sponsor

Heart Care Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT01971125

Collaborator

(none)

970

Enrollment

Locations

Duration (Months)

69.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Heart Diseases Left Ventricular Dysfunction

Study Design

Study Type:

Observational

Actual Enrollment :

970 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Left Ventricular DYsfunction in DiAbetes

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Prevalence of Left Ventricular Dysfunction in patients with type II diabetes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casa di Cura Pineta del Carso	Duino - Aurisina	Friuli - Venezia Giulia	Italy	34011
2	A.O.- Univ. Ospedali Riuniti	Trieste	Friuli - Venezia Giulia	Italy	34100
3	Azienda Servizi Sanitari N°1 Triestina	Trieste	Friuli - Venezia Giulia	Italy	34100
4	Presidio Ospedaliero	Sanremo	Liguria	Italy	18038
5	Ospedali Riuniti	Bergamo	Lombardia	Italy	24100
6	Spedali Civili	Brescia	Lombardia	Italy	25100
7	Ospedale San Raffaele	Milano	Lombardia	Italy	20010
8	Ospedale San Paolo	Milano	Lombardia	Italy	20100
9	Istituto Clinico Humanitas	Rozzano	Lombardia	Italy	20089
10	IRCCS Policlinico Multimedica	Sesto San Giovanni	Lombardia	Italy	20099
11	Ospedale Maggiore	Chieri	Piemonte	Italy	10023
12	A.O. Santa Croce e Carle	Cuneo	Piemonte	Italy	12100
13	Ospedale Mauriziano	Torino	Piemonte	Italy	10125
14	Ospedale Civile	Mirano	Veneto	Italy	30035