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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
- 電話番号：+82-31-8086-2869
- メール：hunjeechoe@gmail.com
研究連絡先のバックアップ
- 名前：Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC
- 電話番号：+82-10-4694-3886
- メール：geumzzogi@naver.com
研究場所
-
-
Gyeonggi-do
-
Hwaseong-si、Gyeonggi-do、韓国、18450
- Hallym University Dongtan Sacred Heart Hospital
-
コンタクト：
- Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
- 電話番号：+82-10-9493-5703
- メール：hunjeechoe@gmail.com
-
Seongnam-si、Gyeonggi-do、韓国、13620
- Seoul National University Bundang Hospital
-
コンタクト：
- Soo Lim Seoul National University Bundang Hospital, MD, PhD
- 電話番号：+82-10-9766-2706
- メール：limsoo@snu.ac.kr
-
コンタクト：
- Soo Lim Seoul National University Bundang Hospital, MD, PhD
- 電話番号：+82-010-9766-2706
- メール：limsoo@snu.ac.kr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 20-70 years at the time of enrollment
- Initiating semaglutide (Wegovy) treatment for obesity (newly starting treatment)
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)
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Diagnosis of type 1 or type 2 diabetes mellitus
- History of neck surgery or radiation therapy to the neck
- Use of anti-obesity medications within 1 month prior to enrollment, or current use of beta-adrenergic blocking agents
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
- Active malignancy, severe renal disease (eGFR <30 mL/min/1.73m²), severe hepatic disease, or other severe endocrine disorders
- Pregnancy or breastfeeding
- Severe psychiatric illness or cognitive impairment precluding informed consent
- Contraindication to MRI (pacemaker, cochlear implant, non-MRI-compatible implants)
- Severe claustrophobia
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
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.
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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in waist circumference
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in body weight (kg)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in Body Mass Index (BMI)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in HbA1c (%)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in fasting glucose (mg/dL)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in HOMA-IR
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in fasting lipids (LDL-C, HDL-C, TG, TC)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in liver fat fraction (MRI-PDFF, %)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in liver stiffness by MRE (kPa)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in adipokines (adiponectin, leptin, NEFA)
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
Change in hsCRP
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
BAT-positive rate based on SUVmax at baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline to 24 weeks
|
Baseline to 24 weeks
|
|
|
BAT-positive rate based on CT Hounsfield Units (HU) at baseline
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年2月1日
研究の完了 (推定)
2031年2月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-04-009
- RS-2026-25483260 (その他の助成金/資金番号：National Research Foundation of Korea)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared publicly.
De-identified aggregate results will be published in peer-reviewed journals
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。