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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
-
-
Istanbul
-
Istanbul, Istanbul, Турция (Туркие), 34093
- Рекрутинг
- Istanbul University, Istanbul Faculty of Medicine
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Контакт:
- DERYA BUDAK BEHRAD, MD
- Номер телефона: +90 545 628 0553
- Электронная почта: derya.budakbehrad@istanbul.edu.tr
-
Контакт:
- ADEM TELLIOGLU, MD
- Номер телефона: +90 5066107361
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Retinal Nerve Fiber Layer Thickness
Временное ограничение: Baseline to up to 18 months
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Visual Acuity
Временное ограничение: Baseline to up to 18 months
|
Change in visual acuity from baseline during follow-up |
Baseline to up to 18 months
|
|
Change in Intraocular Pressure
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Расстройства питания
- Метаболические заболевания
- Переедание
- Масса тела
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Избыточный вес
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Ожирение
- Сахарный диабет, тип 2
- Аминокислоты, пептиды и белки
- Белки
- Глюкагоноподобный рецептор пептида-1
- Глюкагоноподобные пептидные рецепторы
- Рецепторы, G-белок связаны
- Рецепторы, клеточная поверхность
- Мембранные белки
- Рецепторы, желудочно -кишечный гормон
- Рецепторы, пептид
- Тирзепатид
- полуглутид
Другие идентификационные номера исследования
- 2025/2444
Планирование данных отдельных участников (IPD)
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продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .