Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity (GLP-NIT)
13 de julio de 2026 actualizado por: Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
Early Changes in Non-Invasive Hepatic and Metabolic Indices After Incretin-Based Therapy in Patients With Overweight or Obesity: Real-World Evidence From a Turkish Cohort
This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose [TyG] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk reduction related to metabolic dysfunction-associated steatotic liver disease (MASLD).
Baseline and follow-up (minimum 12 weeks) clinical, anthropometric, and laboratory data from 154 patients treated at a single tertiary-care center in Turkey were analyzed.
The study assessed whether short-term incretin-based therapy was associated with changes in fibrosis-related indices (FIB-4, APRI) versus steatosis- and insulin resistance-related indices (HSI, TyG), and identified independent predictors of these changes using multivariable linear regression.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adults aged 18 years or older with overweight or obesity who were considered at increased metabolic risk for MASLD and who received continuous subcutaneous semaglutide or tirzepatide for at least 12 weeks were retrospectively identified at the internal medicine clinic of a tertiary-care state hospital in Istanbul, Turkey. Patients with significant alcohol consumption, other chronic liver disease etiologies, prior bariatric surgery, recent initiation/dose change of MASLD-relevant medications, concurrent hepatotoxic agent use, or missing baseline/follow-up data were excluded.
Baseline values were defined as the most recent measurements within 4 weeks before treatment initiation; follow-up values were the earliest measurements obtained after at least 12 continuous weeks of therapy. FIB-4, APRI, HSI, and TyG were calculated at both time points. Wilcoxon signed-rank tests compared baseline-to-follow-up changes. Kendall's tau assessed exploratory correlations among change scores; Spearman's rho assessed two prespecified correlations (percentage body-weight change vs. index changes; ΔHbA1c vs. index changes in the diabetic subgroup). Multivariable linear regression (enter method) identified independent predictors of ΔFIB-4, ΔAPRI, ΔHSI, and ΔTyG, adjusting for baseline index value, weight change, follow-up duration, baseline HbA1c, sex, and age.
Agent choice (semaglutide vs. tirzepatide) and dose titration were at the discretion of the treating physician; patients receiving either agent were analyzed together as a drug class, without dose-based stratification, since the study's aim was to characterize the class-level early index response rather than compare individual agents.
Tipo de estudio
De observación
Inscripción (Actual)
154
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adults with overweight or obesity at increased metabolic risk for MASLD, treated with subcutaneous semaglutide or tirzepatide for at least 12 weeks at a single tertiary-care internal medicine clinic in Turkey; both medications were self-funded (out-of-pocket), as they are not covered by the national health insurance system.
Descripción
Inclusion Criteria:
- Adults aged 18 years or older
- Overweight (BMI 25.0-29.9 kg/m²) or obesity (BMI ≥30.0 kg/m²)
- Considered at increased metabolic risk for MASLD (overweight/obesity plus ≥1 additional cardiometabolic risk factor)
- Continuous treatment with subcutaneous semaglutide or tirzepatide for at least 12 weeks
Exclusion Criteria:
- Significant alcohol consumption (>30 g/day for men; >20 g/day for women)
- Chronic liver disease of other etiology (viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease)
- Prior bariatric surgery
- Initiation or dose modification of pioglitazone, SGLT-2 inhibitors, or high-dose vitamin E within 3 months before baseline
- Concurrent use of known hepatotoxic agents (e.g., amiodarone, methotrexate)
- Missing clinical, anthropometric, or laboratory data at baseline or follow-up
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Semaglutide
Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous semaglutide for at least 12 weeks (n=81).
Dose titration was at the treating physician's discretion.
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Once-weekly subcutaneous GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
Otros nombres:
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Tirzepatide
Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous tirzepatide for at least 12 weeks (n=73).
Dose titration was at the treating physician's discretion.
|
Once-weekly subcutaneous dual GIP/GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Fibrosis-4 Index (FIB-4)
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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FIB-4 = (Age × AST) / (Platelet count × √ALT), calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in AST-to-Platelet Ratio Index (APRI)
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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APRI = (AST / 40 U/L ULN) / Platelet count × 100, calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in Hepatic Steatosis Index (HSI)
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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HSI = 8 × (ALT/AST) + BMI + 2 (if type 2 diabetes) + 2 (if female), calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in Triglyceride-Glucose (TyG) Index
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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yG = ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) / 2], calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Liver Enzymes
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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AST, ALT, and GGT levels (U/L).
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Baseline and follow-up (median 23.7 weeks)
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Change in Lipid Profile
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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Total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)
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Baseline and follow-up (median 23.7 weeks)
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Change in Fasting Plasma Glucose
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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Fasting plasma glucose (mg/dL)
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Baseline and follow-up (median 23.7 weeks)
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Change in Body Weight
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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Body weight (kilograms).
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Baseline and follow-up (median 23.7 weeks)
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Change in Glycated Hemoglobin (HbA1c)
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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HbA1c (percentage of total hemoglobin, %).
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Baseline and follow-up (median 23.7 weeks)
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Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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BMI (kg/m^2), calculated from body weight and height.
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Baseline and follow-up (median 23.7 weeks)
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Change in Waist-to-Height Ratio
Periodo de tiempo: Baseline and follow-up (median 23.7 weeks)
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Waist-to-height ratio (unitless ratio: waist circumference [cm] / height [cm]).
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Baseline and follow-up (median 23.7 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ozgur Bahadir, MD, Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
- Director de estudio: Ayse N Erbakan, MD,PhD, Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2024
Finalización primaria (Actual)
30 de marzo de 2026
Finalización del estudio (Actual)
15 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Enfermedades del Sistema Digestivo
- Trastornos del metabolismo de la glucosa
- Enfermedades del HIGADO
- Hiperinsulinismo
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Hígado graso
- Resistencia a la insulina
- Aminoácidos, péptidos y proteínas
- Proteínas
- Receptor de péptido-1 tipo glucagón
- Receptores de péptidos tipo glucagón
- Receptores, acoplados a la proteína G
- Receptores, superficie celular
- Proteínas de membrana
- Receptores, hormona gastrointestinal
- Receptores, péptido
- Tirzepatide
- semaglutida
Otros números de identificación del estudio
- GLP-NIT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data available from the corresponding author upon reasonable request
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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