Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)

NCT04933188 | Recruiting

• 1 other identifier: ACFO2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  within 24 hours of the recruitment

Study Arms (3)

control

Lean health controls with a BMI\<25kg/m2

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

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

Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure

Interventions

Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure DIAGNOSTIC_TEST

Baseline and follow-up examination of echocardiography is to be performed on study subjects.

control; obesity; overweight

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

overweight or obese subjects referred to the endocrinology inpatients

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Ningbo Hangzhou Bay Hospital: collaborator
• Jiading Central Hospital: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Meng Jiang

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Hang Zhao

CONTACT

+8613764477850; zara_hang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: June 21, 2021
• Study Start: May 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (1)