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Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function

2026年4月29日 更新者：Itshak Amsalem

The goal of this observational study is to learn if weight loss surgery can lower fat inside the heart muscle and improve how the heart relaxes in adults with obesity.

The main questions it aims to answer are:

Does fat inside the heart muscle decrease after weight loss surgery? Does heart relaxation (diastolic function) improve after surgery? Are changes in heart fat linked to changes in weight, body fat, and blood markers?

Participants who are already planning to have weight loss surgery will take part in this study.

Participants will:

Have a heart CT scan to measure fat in the heart muscle before surgery and about 6 months after surgery Have an ultrasound of the heart (echocardiogram) to check how the heart fills and relaxes Have body composition testing to measure fat and muscle Have blood tests, including routine tests and additional markers related to heart function and metabolism

Researchers will compare each participant's results before and after surgery to see if heart fat decreases and if heart function and blood markers improve.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Adults with obesity who are scheduled to undergo bariatric surgery for standard clinical care at a tertiary medical center. Participants will be recruited during their preoperative evaluation and will undergo baseline and follow-up assessments, including cardiac imaging and clinical measurements, as part of the study.

描述

Inclusion Criteria:

  • Adults aged 18 years or older
  • Scheduled to undergo bariatric surgery for standard clinical indications
  • Left ventricular ejection fraction (LVEF) ≥50%
  • Able to undergo cardiac computed tomography (CT)

Exclusion Criteria:

  • Left ventricular ejection fraction (LVEF) <50%
  • Known cardiomyopathies, including sarcoidosis, amyloidosis, or myocarditis
  • Significant valvular heart disease
  • Contraindication to cardiac CT (e.g., severe renal dysfunction, contrast allergy)
  • Presence of intracardiac or cardiac-related foreign material that may interfere with imaging (e.g., prosthetic valves, pacemakers, prior transcatheter devices)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Adults Undergoing Bariatric Surgery

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in intramyocardial fat content assessed by cardiac CT
大体时间：Baseline to 6 months
Change in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
Baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Correlation coefficient between change in intramyocardial fat and change in diastolic function grade
大体时间：Baseline to 6 months
Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac computed tomography (CT) as a percentage of myocardial volume, and change in diastolic function grade assessed by transthoracic echocardiography according to guideline-based criteria
Baseline to 6 months
Change in diastolic function grade
大体时间：Baseline to 6 months
Change in diastolic function grade assessed by transthoracic echocardiography according to standard guideline-based criteria (including parameters such as E/e', left atrial volume index, and other measures of left ventricular filling pressures) between baseline and 6 months
Baseline to 6 months
Change in body composition
大体时间：Baseline to 6 months
Change in total fat mass and lean body mass assessed by body composition analysis between baseline and 6 months
Baseline to 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
大体时间：Baseline to 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, measured in pg/mL using standard laboratory assays, between baseline and 6 months
Baseline to 6 months
Change in pericardial fat volume
大体时间：Baseline to 6 months
Change in pericardial fat volume quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
Baseline to 6 months
Correlation coefficient between change in intramyocardial fat and change in body weight
大体时间：Baseline to 6 months
Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac CT as a percentage of myocardial volume, and change in body weight measured in kilograms
Baseline to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Itshak Amsalem

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年4月15日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SZMC-0044-26

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Individual participant data (IPD) sharing is currently undecided. Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations. If shared, only de-identified data will be made available to qualified researchers upon reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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