Left Ventricular DYsfunction in DiAbetes

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2009

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of Left Ventricular Dysfunction in patients with type II diabetes
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heart Care Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marco Comaschi, M.D., Study Chair,
    • Andrea di Lenarda, M.D., Study Chair,

References

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.

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.

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.

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.

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.

Citations Reporting on Results

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.

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