A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes

NCT ID: NCT04964713

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Prognosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

normal glucose metabolism(NGM)

Assessing the left heart and right heart structure and function of NGM by speckle tracking echocardiography.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

people with T2DM according to the WHO 2006 criteria

Exclusion Criteria

including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
Minimum Eligible Age

35 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xie Mingxing

OTHER

Sponsor Role lead

Responsible Party

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Xie Mingxing

Head of Department of Ultrasound, Union Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jing Jing, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Central Contacts

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Jing Wang, PhD

Role: CONTACT

13397105628

Li Zhang, PhD

Role: CONTACT

18907131488

Other Identifiers

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2021 V1.0

Identifier Type: -

Identifier Source: org_study_id

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