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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mi-Hee JANG, MD
- Numer telefonu: 82-52-250-7000
- E-mail: 0736353@uuh.ulsan.kr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
; 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
Opis
## 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]
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Adults aged 19 years or older who underwent health examinations at Ulsan University Hospital
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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]
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Patients who are unable to undergo follow-up CT examinations.
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Patients who are unable to continue GLP-1 RA therapy during the study period.
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: OTHER
Kohorty i interwencje
Grupa / 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in the Ratio of Low-attenuation Muscle Area to Total abdominal muscle area (LAMA/TAMA Ratio)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Total abdominal muscle area (TAMA)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UUH 2026-09-050-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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