Changes in Body Composition and Muscle Composition After GLP-1 Receptor Agonist Therapy in Patients With Obesity
Changes in Body Composition and Muscle Composition After GLP-1 Receptor Agonist Therapy in Patients With Obesity; A CT-Based Longitudinal Study
This study aims to evaluate changes in body composition and skeletal muscle composition following glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy in adults with obesity or overweight with weight-related comorbidities. Ulsing computed tomography (CT), the study will quantitatively assess changes in skeletal muscle quantity, muscle attenuation, and adipose tissue distribution before and after treatment.
This is a single-center observational study consisting of a prospective GLP-1RA treatment cohort and a retrospective matched control cohort. A total of 240 participants will be included, comprising 120 patients receiving GLP-1RA therapy and 120 matched controls. The study aims to clarify whether changes in body composition following GLP-1 RA therapy reflect reductions in skeletal muscle quantity, changes in muscle composition, or both.
Přehled studie
Postavení
Podmínky
Detailní popis
Obesity is a major risk factor for metabolic and cardiovascular diseases. GLP-1 receptor agonists, including semaglutide and tirzepatide, have demonstrated substantial weight-reducing effects and are increasingly used in clinical practice. However, the effects of GLP-1 RA therapy on skeletal muscle quantity and quality remain incompletely understood.
Previous studies using dual-energy X-ray absorptiometry or bioelectrical impedance analysis have reported reductions in lean mass following GLP-1RA therapy. Nevertheless, lean mass includes non-muscle components, and these methods have limitations in distinguishing skeletal muscle tissue from intramuscular or intermuscular adipose tissue.
CT-based body composition analysis allows quantitative assessment of skeletal muscle area, muscle attenuation, and adipose tissue distribution. This study will evaluate changes in these parameters at the third lumbar vertebral level (L3) before and approximately 12 ± 6 months after GLP-1RA treatment initiation.
The prospective cohort will include 120 adults who are newly prescribed GLP-1RA therapy as part of routine clinical care at Ulsan University Hospital. Participants will undergo non-contrast CT examinations at baseline and follow-up. Clinical measurements, laboratory findings, handgrip strength will also be assessed. In addition, questionnaire-based assessments of quality of life, physical activity, depression, and anxiety will be conducted as specified in the study protocol.
A retrospective control cohort of 120 adults who previously underwent health examinations and had at least two CT scans separated by one year or longer will bel selected. Controls will be matched to the treatment cohort by age, sex, and body mass index.
The primary outcomes are changes in the ratio of low-attenuation muscle area to total abdominal muscle area and extramyocellular lipid area. Secondary outcomes include changes in total abdominal muscle area, visceral and subcutaneous fat area, anthropometric measurements, and other clinical parameters.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Mi-Hee JANG, MD
- Telefonní číslo: 82-52-250-7000
- E-mail: 0736353@uuh.ulsan.kr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
; Adults aged 19 years or older receiving clinical care at Ulsan University Hospital will be included. The prospective treatment cohort will consist of patients with obesity or overweight with at least one weight-related comorbidity who are newly prescribed GLP-1RA therapy. The retrospective control cohort will consist of adults who underwent health examinations and had at least two abdominal CT examinations separated by at least one year. Controls will be matched to treated patients according to age, sex, and BMI
Popis
## Inclusion criteria [Prospective GLP-1RA treatment cohort]
- Adults aged 19 years or older.
- Patients with a BMI ≥30 kg/㎡, or a BMI ≥27 kg/㎡ and < 30 kg/㎡ with at least one weight-related comorbidity.
- Patients for whom GLP-1 RA therapy has been initiated or planned based on clinical judgement.
- Patients who voluntarily provide written informed consent to participate in the study.
[Retrospective Matched Control cohort]
-
Adults aged 19 years or older who underwent health examinations at Ulsan University Hospital
-
Individuals who underwent at least two abdominal computed tomography (CT) examinations separated by an interval of at least one year.
## Exclusion criteria [Prospective GLP-1RA treatment cohort]
-
Patients who are unable to undergo follow-up CT examinations.
-
Patients who are unable to continue GLP-1 RA therapy during the study period.
-
Patients with severe medical conditions that may substantially affect skeletal muscle mass or body composition.
[Retrospective Matched Control cohort]
∙ Individuals with insufficient abdominal CT images or clinical data for evaluating longitudinal changes in body composition.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: OTHER
Kohorty a intervence
Skupina / kohorta |
|---|
|
Group 1 - GLP-1 RA treatment cohort
Adults with obesity with weight-related comorbidities who initiate GLP-1RA therapy as part of routine clinical care. Participants will undergo non-contrast CT examinations at baseline and approximately 12±6 months after treatment initiation. Body composition, muscle composition, and relevant clinical parameters will be assessed longitudinally. |
|
Retrospective Matched Control Cohort
Adults who previously underwent health examinations at Ulsan University Hospital and had at least two abdominal CT scans separated by at least one year. Participants will be retrospectively selected and matched 1:1 to the GLP-1 RA treatment cohort according to age, sex, and BMI. Existing CT images and clinical records will be used to evaluate longitudinal changes in body composition. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in the Ratio of Low-attenuation Muscle Area to Total abdominal muscle area (LAMA/TAMA Ratio)
Časové okno: Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Change in the percentage of low-attenuation muscle area relative to total abdominal muscle area, measured using non-contrast abdominal CT at the third lumbar vertebra level |
Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Total abdominal muscle area (TAMA)
Časové okno: Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Change in total abdominal muscle area, measured using non-contrast abdominal CT at the L3 level |
Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
|
Change in Visceral Fat Area (VFA)
Časové okno: Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Change in visceral fat area, measured using non-contrast abdominal CT at the L3 level. |
Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
|
Change in Subcutaneous Fat Area (SFA)
Časové okno: Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Change in subcutaneous fat area, measured using non-contrast abdominal CT at the L3 level. |
Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
|
Change in Handgrip Strength
Časové okno: Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Change in maximal handgrip strength, assessed using a hand dynamometer at baseline and follow-up. |
Baseline to approximately 12±6 months after GLP-1RA treatment initiation
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UUH 2026-09-050-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
It is currently undecided whether individual participant data will be shared. Any future data sharing will be subject to institutional policies, ethical considerations, and applicable regulations.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .