DiabetesNCT04964713
A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes
An observational study of Diabetes and Prognosis, run by Xie Mingxing.
Trial summary
The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. Read more about this study
- Who is it for?
- Ages 35 to 79 yearsHealthy volunteers can take part
- How many people
- 2,300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with type 2 diabetes mellitus and prediabetes were diagnosed according to the WHO 2006 criteria, aged 35 -79 years, who are undergoing echocardiography examination in clinical needs.
Who may be able to join
- people with T2DM according to the WHO 2006 criteria
Who cannot join
- including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes Mellitus
The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
Read the detailed description
This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
- Medical subject headings
- Diabetes Mellitus
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 |
|---|---|---|
| type 2 diabetes | T2DM was defined according to the WHO 2006 criteria. Assessing the left heart and right heart structure and function of T2DM by speckle tracking echocardiography. | |
| Prediabetes | According to the WHO 2006 criteria, combining impaired fasting glucose and impaired glucose tolerance as prediabetes. Assessing the left heart and right heart structure and function of prediabetes by speckle tracking echocardiography. | |
| normal glucose metabolism(NGM) | Assessing the left heart and right heart structure and function of NGM by speckle tracking echocardiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
including myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure
Measured: through study completion, an average of 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xie Mingxing
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xie Mingxing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Jing Jing, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964713
- Sponsor's protocol ID
- 2021 V1.0
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04964713
- Acronym / sponsor ID
- 2021 V1.0
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Xie MingxingUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Jul 2021 (actual)
- 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 aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
Detailed description
This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | –T2DM was defined according to the WHO 2006 criteria. Assessing the left heart and right heart structure and function of T2DM by speckle tracking echocardiography. |
| Prediabetes | – | –According to the WHO 2006 criteria, combining impaired fasting glucose and impaired glucose tolerance as prediabetes. Assessing the left heart and right heart structure and function of prediabetes by speckle tracking echocardiography. |
| normal glucose metabolism(NGM) | – | –Assessing the left heart and right heart structure and function of NGM by speckle tracking echocardiography. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with type 2 diabetes mellitus and prediabetes were diagnosed according to the WHO 2006 criteria, aged 35 -79 years, who are undergoing echocardiography examination in clinical needs.
Key inclusion criteria (1 listed)
- people with T2DM according to the WHO 2006 criteria
Key exclusion criteria (1 listed)
- including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
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
major adverse cardiovascular events
Time frame: through study completion, an average of 6 year
including myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jing Jing, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Prognosis, run by Xie Mingxing.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang, PhD (13397105628, 2419676@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: through study completion, an average of 6 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.