Ocular Changes in Patients Using Tirzepatide or Semaglutide
Evaluation of Optic Nerve Head, Retinal Changes, and Choroidal Blood Flow in Patients With Diabetes and Obesity Using Tirzepatide or Semaglutide
This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.
Participants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods.
The study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This prospective observational cohort study will evaluate ocular structural and microvascular changes in adults with obesity receiving semaglutide or tirzepatide as part of routine clinical care. Participants will include individuals with and without type 2 diabetes mellitus.
The study population will be divided into four observational cohorts according to diabetes status and medication use:
- Participants with obesity and type 2 diabetes receiving semaglutide.
- Participants with obesity and type 2 diabetes receiving tirzepatide.
- Participants with obesity without type 2 diabetes receiving semaglutide.
- Participants with obesity without type 2 diabetes receiving tirzepatide.
Participants will undergo ophthalmologic examinations at baseline and during follow-up for up to 18 months. Assessments will include visual acuity, slit-lamp examination, intraocular pressure measurement, fundus examination, optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and enhanced depth imaging optical coherence tomography (EDI-OCT).
The study will evaluate changes in retinal nerve fiber layer thickness, retinal thickness, superficial and deep retinal vessel density, foveal avascular zone area, choriocapillaris flow deficit percentage, and choroidal thickness. Changes in visual acuity and intraocular pressure will also be assessed.
Ocular measurements obtained at baseline and during follow-up will be compared to investigate structural and microvascular changes associated with semaglutide or tirzepatide treatment. Differences between the observational cohorts may also be evaluated.
All medications will be prescribed by the treating physicians as part of routine clinical care. Treatment selection will not be determined by the study protocol, and no experimental ophthalmologic intervention will be performed.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34093
- Reclutamiento
- Istanbul University, Istanbul Faculty of Medicine
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Contacto:
- DERYA BUDAK BEHRAD, MD
- Número de teléfono: +90 545 628 0553
- Correo electrónico: derya.budakbehrad@istanbul.edu.tr
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Contacto:
- ADEM TELLIOGLU, MD
- Número de teléfono: +90 5066107361
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care will be included. Participants will include individuals with and without type 2 diabetes mellitus. The study population will be evaluated in four observational cohorts according to diabetes status and medication: obesity with diabetes receiving semaglutide, obesity with diabetes receiving tirzepatide, obesity without diabetes receiving semaglutide, and obesity without diabetes receiving tirzepatide.
Descripción
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of obesity
- Receiving semaglutide or tirzepatide as part of routine clinical care
- Participants with or without type 2 diabetes mellitus
- Availability for baseline and follow-up ophthalmologic examinations
Exclusion Criteria:
- Age under 18 years
- Not receiving semaglutide or tirzepatide
- Inability to complete the required ophthalmologic examinations or imaging assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Obesity With Diabetes - Semaglutide
Participants with obesity and diabetes receiving semaglutide as part of routine clinical care. |
Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up. |
|
Obesity With Diabetes - Tirzepatide
Participants with obesity and diabetes receiving tirzepatide as part of routine clinical care |
Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up. |
|
Obesity Without Diabetes - Semaglutide
Participants with obesity without diabetes receiving semaglutide as part of routine clinical care |
Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up. |
|
Obesity Without Diabetes - Tirzepatide
Participants with obesity without diabetes receiving tirzepatide as part of routine clinical care |
Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Retinal Nerve Fiber Layer Thickness
Periodo de tiempo: Baseline to up to 18 months
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Change in retinal nerve fiber layer thickness from baseline during follow-up, assessed using optical coherence tomography (OCT). |
Baseline to up to 18 months
|
|
Change in Retinal Thickness
Periodo de tiempo: Baseline to up to 18 months
|
Change in retinal thickness from baseline during follow-up, assessed using optical coherence tomography (OCT). |
Baseline to up to 18 months
|
|
Change in Superficial Retinal Vessel Density
Periodo de tiempo: Baseline to 18 months
|
Change in superficial retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%). |
Baseline to 18 months
|
|
Change in Deep Retinal Vessel Density
Periodo de tiempo: Baseline to 18 months
|
Change in deep retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%). |
Baseline to 18 months
|
|
Change in Foveal Avascular Zone Area
Periodo de tiempo: Baseline to 18 months
|
Change in foveal avascular zone (FAZ) area from baseline to follow-up, measured using optical coherence tomography angiography (OCT-A) and expressed in square millimeters (mm²). |
Baseline to 18 months
|
|
Change in Choriocapillaris Flow Deficit Percentage
Periodo de tiempo: Baseline to 18 months
|
Change in choriocapillaris flow deficit percentage from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%). |
Baseline to 18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Visual Acuity
Periodo de tiempo: Baseline to up to 18 months
|
Change in visual acuity from baseline during follow-up |
Baseline to up to 18 months
|
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Change in Intraocular Pressure
Periodo de tiempo: Baseline to up to 18 months
|
Change in intraocular pressure from baseline during follow-up, measured in mmHg during routine ophthalmologic examination. |
Baseline to up to 18 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Diabetes Mellitus, Tipo 2
- 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
- 2025/2444
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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