NCT01971125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
970

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

September 25, 2023

Status Verified

October 1, 2013

Enrollment Period

2.7 years

First QC Date

October 23, 2013

Last Update Submit

September 22, 2023

Conditions

Diabetes Mellitus, Type 2Heart DiseasesLeft Ventricular Dysfunction

Keywords

Diabetes Mellitus, Type 2Heart DiseasesLeft Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Casa di Cura Pineta del Carso

Duino-Aurisina, Friuli Venezia Giulia, 34011, Italy

Location

A.O.- Univ. Ospedali Riuniti

Trieste, Friuli Venezia Giulia, 34100, Italy

Location

Azienda Servizi Sanitari N°1 Triestina

Trieste, Friuli Venezia Giulia, 34100, Italy

Location

Presidio Ospedaliero

Sanremo, Liguria, 18038, Italy

Location

Ospedali Riuniti

Bergamo, Lombardy, 24100, Italy

Location

Spedali Civili

Brescia, Lombardy, 25100, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20010, Italy

Location

Ospedale San Paolo

Milan, Lombardy, 20100, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Policlinico Multimedica

Sesto San Giovanni, Lombardy, 20099, Italy

Location

Ospedale Maggiore

Chieri, Piedmont, 10023, Italy

Location

A.O. Santa Croce e Carle

Cuneo, Piedmont, 12100, Italy

Location

Ospedale Mauriziano

Turin, Piedmont, 10125, Italy

Location

Ospedale Civile

Mirano, Veneto, 30035, Italy

Location

Related Publications (6)

  • 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.

    PMID: 9727886BACKGROUND

  • 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.

    PMID: 21798988BACKGROUND

  • 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.

    PMID: 21881524BACKGROUND

  • 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.

    PMID: 23806478BACKGROUND

  • 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.

    PMID: 23970719BACKGROUND

  • 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.

    PMID: 21450640RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart DiseasesVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular DiseasesVentricular Dysfunction

Study Officials

  • Marco Comaschi, M.D.

    STUDY CHAIR

  • Andrea di Lenarda, M.D.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

November 1, 2010

Last Updated

September 25, 2023

Record last verified: 2013-10

Locations

IT(14)