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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye), 34093
- Rekrytering
- Istanbul University, Istanbul Faculty of Medicine
-
Kontakt:
- DERYA BUDAK BEHRAD, MD
- Telefonnummer: +90 545 628 0553
- E-post: derya.budakbehrad@istanbul.edu.tr
-
Kontakt:
- ADEM TELLIOGLU, MD
- Telefonnummer: +90 5066107361
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Retinal Nerve Fiber Layer Thickness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Visual Acuity
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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- Övervikt
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
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- Membranproteiner
- Receptorer, gastrointestinalt hormon
- Receptorer, peptid
- Tirzepatid
- semaglutid
Andra studie-ID-nummer
- 2025/2444
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