Diabetes Mellitus, Type 2DYDANCT01971125
Left Ventricular DYsfunction in DiAbetes
An observational study of Diabetes Mellitus, Type 2 and Heart Diseases, run by Heart Care Foundation at 14 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Diseases, Left Ventricular Dysfunction
- How many people
- 970 participants
- Where
- 14 sitesItaly
- Study dates
- Jul 2006to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- diabetes mellitus type 2
- absence of heart disease previously reported
- age >45 years
- Informed Consent
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Ospedali Riuniti
Bergamo, Lombardy, 24100
Spedali Civili
Brescia, Lombardy, 25100
Ospedale Maggiore
Chieri, Piedmont, 10023
A.O. Santa Croce e Carle
Cuneo, Piedmont, 12100
Casa di Cura Pineta del Carso
Duino-Aurisina, Friuli Venezia Giulia, 34011
Ospedale San Raffaele
Milan, Lombardy, 20010
Ospedale San Paolo
Milan, Lombardy, 20100
Ospedale Civile
Mirano, Veneto, 30035
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
Presidio Ospedaliero
Sanremo, Liguria, 18038
IRCCS Policlinico Multimedica
Sesto San Giovanni, Lombardy, 20099
A.O.- Univ. Ospedali Riuniti
Trieste, Friuli Venezia Giulia, 34100
Azienda Servizi Sanitari N°1 Triestina
Trieste, Friuli Venezia Giulia, 34100
Ospedale Mauriziano
Turin, Piedmont, 10125
About this study
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.
- Keywords
- Diabetes Mellitus, Type 2, Heart Diseases, Left Ventricular Dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: left ventricula dysfunction at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Care Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Comaschi, M.D., Study chairAndrea di Lenarda, M.D., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971125
- Sponsor's protocol ID
- G 107
- Acronym
- DYDA
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9727886Cioffi 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.
PubMed 21798988Cioffi 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.
PubMed 21881524Cioffi 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.
PubMed 23806478Masson 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.
PubMed 23970719Giorda 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.
PubMed 21450640
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular DYsfunction in DiAbetes
- ClinicalTrials.gov ID
- NCT01971125
- Acronym / sponsor ID
- DYDA / G 107
- Keywords
- Diabetes Mellitus, Type 2, Heart Diseases, Left Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Heart Care FoundationUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- diabetes mellitus type 2
- absence of heart disease previously reported
- age >45 years
- Informed Consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 9727886King 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.
- Background: PubMed 21798988Cioffi 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.
- Background: PubMed 21881524Cioffi 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.
- Background: PubMed 23806478Cioffi 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.
- Background: PubMed 23970719Masson 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.
- Results publication: PubMed 21450640Giorda 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Comaschi, M.D. study chair
Andrea di Lenarda, M.D. study chair
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Heart Diseases, run by Heart Care Foundation at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Left Ventricular Dysfunction in patients with type II diabetes (time frame: left ventricula dysfunction at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971125, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.