Overweight and ObesityNCT04933188
Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)
An observational study of Overweight and Obesity, run by RenJi Hospital at 1 site in China.
Trial summary
This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Dec 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: overweight or obese subjects referred to the endocrinology inpatients
Who may be able to join
- All patients were older than 18 without any cardiac symptoms.
- The diagnosis of overweight was established when body mass index (BMI) of 25 to 30 kg/m2.
- Obese was defined as a BMI of 30 kg/m2 or higher.
Who cannot join
- diagnosis of type 2-Diabetes Mellitus according to the American Diabetes Association criteria;
- left ventricular ejection fraction<50% on echocardiography;
- arrythmia on electrocardiogram;
- severe valvular stenosis or regurgitation;
- history of coronary disease (defined as stenosis>50%) or myocardial infarction;
- stress induced wall motion abnormality on echocardiography, coronary artery stenosis >50% on coronary CT or angiography with Framingham risk score of >10;
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- pacemaker or defibrillator implantation;
- the presence of bundle branch block;
- severe infection or renal dysfunction with an estimated glomerular filtration rate < 60 ml/min/1.73 m2);
- inadequate image quality on echocardiography.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Hang Zhao, +8613764477850, zara_hang@163.com
About this study
Official title: Early Detection of Myocardial Work Impairment in Patients With Overweight and Obesity (EARLY-MYO-OBESITY-II)
This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.
Read the detailed description
Obesity significantly increases the risk for heart failure. Early detection of preclinical cardiac dysfunction in overweight or obesity and understanding its association with insulin resistance are of great importance.Recently, a novel technique for myocardial work (MW) assessment has been introduced to evaluate myocardial performance. To date, change of MW has been described in several cardiac conditions including dilated cardiomyopathy, significant coronary arterial diseases, and hypertrophic cardiomyopathy, which implies regional or global myocardial dysfunction. In this study, we aimed to explore the alteration of MW in overweight or obese adults and to determine whether insulin resistance or other clinical risk factors may impact myocardial mechanics before impairment of systolic function.
- Conditions
- Overweight and Obesity
- Being tested
- Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressureDiagnostic test
Baseline and follow-up examination of echocardiography is to be performed on study subjects.
| Study group | Role | What they receive |
|---|---|---|
| control | Lean health controls with a BMI<25kg/m2 Receives: Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure | |
| overweight | patients with a BMI of 25-30kg/m2 Receives: Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure | |
| obesity | patients with a BMI of over 30kg/m2 Receives: Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the change of global myocardial work index (GWI) in overweight or obese patients
GWI derived from echocardiography will be assessed in overweight or obese patients and compare with lean controls
Measured: within 24 hours of the recruitment
investigate the change of global constructive work (GCW) in overweight or obese patients
GCW will be assessed in overweight or obese patients and compare with lean controls
Measured: within 24 hours of the recruitment
investigate the change of global waste work (GWW) in overweight or obese patients
GWW will be assessed in overweight or obese patients and compare with lean controls
Measured: within 24 hours of the recruitment
investigate the change of global work efficiency (GWE) in overweight or obese patients
GWE will be assessed in overweight or obese patients and compare with lean controls
Measured: within 24 hours of the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 May 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital, Jiading Central Hospital
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933188
- Sponsor's protocol ID
- ACFO2020
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao H, Jiang M, Wang W, Tao Z, Wang X, Chai Y, Han Y, Liu Q, Chen Y, Yue J, Qi Y, Li X, Ma J, Pu J. Subclinical myocardial work impairment in non-diabetic overweight and obese individuals: Impact of cardiometabolic traits. Int J Cardiol. 2025 Aug 15;433:133321. doi: 10.1016/j.ijcard.2025.133321. Epub 2025 Apr 26.
PubMed 40294804
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Myocardial Work Impairment in Patients With Overweight and Obesity (EARLY-MYO-OBESITY-II)
- ClinicalTrials.gov ID
- NCT04933188
- Acronym / sponsor ID
- ACFO2020
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital, Jiading Central Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jun 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.
This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.
Detailed description
Obesity significantly increases the risk for heart failure. Early detection of preclinical cardiac dysfunction in overweight or obesity and understanding its association with insulin resistance are of great importance.Recently, a novel technique for myocardial work (MW) assessment has been introduced to evaluate myocardial performance. To date, change of MW has been described in several cardiac conditions including dilated cardiomyopathy, significant coronary arterial diseases, and hypertrophic cardiomyopathy, which implies regional or global myocardial dysfunction. In this study, we aimed to explore the alteration of MW in overweight or obese adults and to determine whether insulin resistance or other clinical risk factors may impact myocardial mechanics before impairment of systolic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressureLean health controls with a BMI<25kg/m2 |
| overweight | – | Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressurepatients with a BMI of 25-30kg/m2 |
| obesity | – | Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressurepatients with a BMI of over 30kg/m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- overweight or obese subjects referred to the endocrinology inpatients
Key inclusion criteria (3 listed)
- All patients were older than 18 without any cardiac symptoms.
- The diagnosis of overweight was established when body mass index (BMI) of 25 to 30 kg/m2.
- Obese was defined as a BMI of 30 kg/m2 or higher.
Key exclusion criteria (10 listed)
- diagnosis of type 2-Diabetes Mellitus according to the American Diabetes Association criteria;
- left ventricular ejection fraction<50% on echocardiography;
- arrythmia on electrocardiogram;
- severe valvular stenosis or regurgitation;
- history of coronary disease (defined as stenosis>50%) or myocardial infarction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressureBaseline and follow-up examination of echocardiography is to be performed on study subjects. | Diagnostic test | control, obesity, overweight |
Primary outcome
investigate the change of global myocardial work index (GWI) in overweight or obese patients
Time frame: within 24 hours of the recruitment
GWI derived from echocardiography will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global constructive work (GCW) in overweight or obese patients
Time frame: within 24 hours of the recruitment
GCW will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global waste work (GWW) in overweight or obese patients
Time frame: within 24 hours of the recruitment
GWW will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global work efficiency (GWE) in overweight or obese patients
Time frame: within 24 hours of the recruitment
GWE will be assessed in overweight or obese patients and compare with lean controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 40294804Zhao H, Jiang M, Wang W, Tao Z, Wang X, Chai Y, Han Y, Liu Q, Chen Y, Yue J, Qi Y, Li X, Ma J, Pu J. Subclinical myocardial work impairment in non-diabetic overweight and obese individuals: Impact of cardiometabolic traits. Int J Cardiol. 2025 Aug 15;433:133321. doi: 10.1016/j.ijcard.2025.133321. Epub 2025 Apr 26.
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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.
Meng Jiang study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hang Zhao (+8613764477850, zara_hang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the change of global myocardial work index (GWI) in overweight or obese patients (time frame: within 24 hours of the recruitment). The study lists 4 primary outcomes in all. 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 NCT04933188, which also lists 1 linked publication.
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 18 Mar 2024.