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

20 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
  • Telefoonnummer: +82-31-8086-2869
  • E-mail: hunjeechoe@gmail.com

Studie Contact Back-up

  • Naam: Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC
  • Telefoonnummer: +82-10-4694-3886
  • E-mail: geumzzogi@naver.com

Studie Locaties

  • Zuid -Korea
    • Gyeonggi-do
      • Hwaseong-si, Gyeonggi-do, Zuid -Korea, 18450
        • Hallym University Dongtan Sacred Heart Hospital
        • Contact:
          • Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
          • Telefoonnummer: +82-10-9493-5703
          • E-mail: hunjeechoe@gmail.com
      • Seongnam-si, Gyeonggi-do, Zuid -Korea, 13620
        • Seoul National University Bundang Hospital
        • Contact:
          • Soo Lim Seoul National University Bundang Hospital, MD, PhD
          • Telefoonnummer: +82-10-9766-2706
          • E-mail: limsoo@snu.ac.kr
        • Contact:
          • Soo Lim Seoul National University Bundang Hospital, MD, PhD
          • Telefoonnummer: +82-010-9766-2706
          • E-mail: limsoo@snu.ac.kr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.
Procedure: 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.
Procedure: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in waist circumference
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in body weight (kg)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in Body Mass Index (BMI)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in HbA1c (%)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in fasting glucose (mg/dL)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in HOMA-IR
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in fasting lipids (LDL-C, HDL-C, TG, TC)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in liver fat fraction (MRI-PDFF, %)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in liver stiffness by MRE (kPa)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in adipokines (adiponectin, leptin, NEFA)
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
Change in hsCRP
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
BAT-positive rate based on SUVmax at baseline
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 24 weeks
Baseline to 24 weeks
BAT-positive rate based on CT Hounsfield Units (HU) at baseline
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hallym University

Medewerkers

Hallym University Dongtan Sacred Heart Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 februari 2031

Studieregistratiedata

Eerst ingediend

20 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-04-009
  • RS-2026-25483260 (Ander subsidie-/financieringsnummer: National Research Foundation of Korea)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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