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

27. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hallym University

Samarbejdspartnere

Hallym University Dongtan Sacred Heart Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. februar 2031

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-04-009
  • RS-2026-25483260 (Andet bevillings-/finansieringsnummer: National Research Foundation of Korea)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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