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Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study) (BAT-Sema)

2026年7月20日 更新者：Hun Jee Choe、Hallym University

Brown Adipose Tissue as a Mechanistic Determinant of GLP-1 Receptor Agonist Treatment Response in Adults With Obesity: A Multicenter Prospective Cohort Study Using ¹⁸FDG-PET/CT and Cold Stimulation Protocol

This study investigates whether the activity of brown adipose tissue (BAT) - a special type of fat that burns energy as heat - can predict how well individuals with obesity respond to semaglutide (Wegovy), a once-weekly injectable weight loss medication. Participants who are starting semaglutide treatment will undergo ¹⁸FDG-PET/CT imaging before and after 24 weeks of treatment. Prior to each PET/CT scan, participants will wear a water-circulating cooling vest to activate BAT. By measuring BAT activity at baseline and comparing it with the degree of weight loss and metabolic improvement at 24 weeks, the investigators aim to identify BAT as a predictive biomarker for personalized obesity treatment.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Despite the remarkable efficacy of semaglutide (GLP-1 receptor agonist) in treating obesity, considerable individual variation in treatment response remains unexplained. Brown adipose tissue (BAT) is a metabolically active thermogenic organ that has been implicated in energy expenditure, insulin sensitivity, and cardiometabolic health. We hypothesize that baseline BAT activity, as measured by ¹⁸FDG-PET/CT following individualized cold stimulation, is a mechanistic determinant of semaglutide treatment response in adults with obesity without diabetes.

This multicenter prospective cohort study will enroll 80 adults (40 per site: Hallym University Dongtan Sacred Heart Hospital and Seoul National University Bundang Hospital) with BMI ≥27 kg/m² plus obesity-related comorbidity, or BMI ≥30 kg/m², who are initiating semaglutide therapy. ¹⁸FDG-PET/CT with standardized cold stimulation (water-circulating cooling vest, starting at 16°C, individualized to prevent shivering) will be performed at baseline (V1) and 24 weeks (V7). BAT activity (SUVmax, SUVmean, BAT volume, total metabolic activity) will be quantified per BARCIST 1.0 criteria. Liver fat fraction (MRI-PDFF) and liver stiffness (MR elastography) will be assessed as secondary endpoints. Correlations between baseline BAT parameters and treatment outcomes (% body weight loss, metabolic biomarker changes) will be analyzed.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

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

  • 姓名：Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
  • 电话号码：+82-31-8086-2869
  • 邮箱：hunjeechoe@gmail.com

研究联系人备份

  • 姓名：Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC
  • 电话号码：+82-10-4694-3886
  • 邮箱：geumzzogi@naver.com

学习地点

  • 韩国
    • Gyeonggi-do
      • Hwaseong-si、Gyeonggi-do、韩国、18450
        • Hallym University Dongtan Sacred Heart Hospital
        • 接触：
          • Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
          • 电话号码：+82-10-9493-5703
          • 邮箱：hunjeechoe@gmail.com
      • Seongnam-si、Gyeonggi-do、韩国、13620
        • Seoul National University Bundang Hospital
        • 接触：
          • Soo Lim Seoul National University Bundang Hospital, MD, PhD
          • 电话号码：+82-10-9766-2706
          • 邮箱：limsoo@snu.ac.kr
        • 接触：
          • Soo Lim Seoul National University Bundang Hospital, MD, PhD
          • 电话号码：+82-010-9766-2706
          • 邮箱：limsoo@snu.ac.kr

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

描述

Inclusion Criteria:

  1. Age 20-70 years at the time of enrollment
  2. Initiating semaglutide (Wegovy) treatment for obesity (newly starting treatment)

  3. BMI ≥ 27 kg/m² with at least one weight-related comorbidity:

    • Hypertension (SBP ≥130 or DBP ≥80 mmHg, or on antihypertensive medication)
    • Dyslipidemia (LDL-C ≥130, TG ≥150, or low HDL-C, or on lipid-lowering medication)
    • Non-alcoholic fatty liver disease (NAFLD/MASLD, confirmed by imaging or ALT/AST ≥1.5× ULN)
    • Obstructive sleep apnea (AHI ≥5/hr or clinically diagnosed)
    • Established cardiovascular disease (CAD, stroke, PAD)
    • Obesity-related osteoarthritis of knee or hip with functional impairment OR BMI ≥ 30 kg/m² (regardless of comorbidity)
  4. Ability and willingness to provide written informed consent

Exclusion Criteria:

  1. Diagnosis of type 1 or type 2 diabetes mellitus
  2. History of neck surgery or radiation therapy to the neck
  3. Use of anti-obesity medications within 1 month prior to enrollment, or current use of beta-adrenergic blocking agents
  4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
  5. Active malignancy, severe renal disease (eGFR <30 mL/min/1.73m²), severe hepatic disease, or other severe endocrine disorders
  6. Pregnancy or breastfeeding
  7. Severe psychiatric illness or cognitive impairment precluding informed consent
  8. Contraindication to MRI (pacemaker, cochlear implant, non-MRI-compatible implants)
  9. Severe claustrophobia

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

  • 主要用途：基础科学
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Semaglutide + BAT Evaluation
Adults with obesity initiating semaglutide (0.25 mg → 2.4 mg over 20 weeks, maintained for 4 weeks; total 24 weeks). At baseline and 24 weeks, ¹⁸FDG-PET/CT with individualized cold stimulation (water-circulating cooling vest at 16°C, 60 minutes) and liver MRI (PDFF + MRE) are performed.
药品：Semaglutide (Wegovy®)
Once-weekly subcutaneous injection, titrated from 0.25 mg to 2.4 mg over 20 weeks per standard protocol. Standard of care treatment for obesity.
程序：¹⁸FDG-PET/CT with cold stimulation
Whole-body ¹⁸FDG-PET/CT (5.18 MBq/kg, max 370 MBq) after 60-minute individualized cold stimulation using a water-circulating cooling vest (Polar Products Arctic Chiller, starting 16°C). Performed at baseline (V1) and 24 weeks (V7). BAT activity quantified per BARCIST 1.0.
程序：Liver MRI (PDFF + MRE)
Hepatic proton density fat fraction (MRI-PDFF) and liver stiffness by MR elastography (MRE) using Siemens MAGNETOM Vida 3T. Performed at baseline (V1) and 24 weeks (V7).

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
Correlation between baseline BAT metabolic activity (SUVmean and BAT volume on ¹⁸FDG-PET/CT) and percentage body weight loss at 24 weeks of semaglutide treatment
大体时间：Baseline to 24 weeks
: Pearson (or Spearman) correlation coefficient between baseline BAT parameters (SUVmean, BAT volume, total metabolic activity per BARCIST 1.0) and % body weight loss after 24 weeks of semaglutide therapy (0.25 mg escalated to 2.4 mg).
Baseline to 24 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in waist circumference
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in body weight (kg)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in Body Mass Index (BMI)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in HbA1c (%)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in fasting glucose (mg/dL)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in HOMA-IR
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in fasting lipids (LDL-C, HDL-C, TG, TC)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in liver fat fraction (MRI-PDFF, %)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in liver stiffness by MRE (kPa)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in adipokines (adiponectin, leptin, NEFA)
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
Change in hsCRP
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
BAT-positive rate based on SUVmax at baseline
大体时间：Baseline
The percentage of participants determined as brown adipose tissue (BAT)-positive, defined by a maximum standardized uptake value (SUVmax) of 1.5 or higher ($\ge 1.5$) at baseline.
Baseline
Change in Quality of life using the Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) total score
大体时间：Baseline to 24 weeks
The Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) is a self-report questionnaire used to assess the quality of life in individuals with obesity. The total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better outcome (better quality of life).
Baseline to 24 weeks
Change in Quality of Life using the Short Form-36 Health Survey Version 2 (SF-36v2) domain scores
大体时间：Baseline to 24 weeks
The Short Form-36 Health Survey Version 2 (SF-36v2) is a 36-item questionnaire measuring health-related quality of life across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better outcome (better health status or higher quality of life).
Baseline to 24 weeks
Change in BAT activity (SUVmax, SUVmean, BAT volume, TMA) from baseline to 24 weeks
大体时间：Baseline to 24 weeks
Baseline to 24 weeks
BAT-positive rate based on CT Hounsfield Units (HU) at baseline
大体时间：Baseline
The percentage of participants determined as brown adipose tissue (BAT)-positive, defined by Computed Tomography Hounsfield Units (CT HU) within the range of $-250$ to $-50$ at baseline.
Baseline

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

Hallym University

合作者

Hallym University Dongtan Sacred Heart Hospital

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6月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2031年2月1日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-04-009
  • RS-2026-25483260 (其他赠款/资助编号：National Research Foundation of Korea)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared publicly. De-identified aggregate results will be published in peer-reviewed journals

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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