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- Klinische proef NCT07605572
Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity (GALENOS)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Vaia Lambadiari, MD, PhD
- Telefoonnummer: (0030)2105838000
- E-mail: vlambadiari@gmail.com
Studie Locaties
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Athens, Griekenland, 12462
- Werving
- 2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and Kapodistrian University of Athens, Athens, GRC.
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Contact:
- Vaia Lambadiari
- Telefoonnummer: (0030)2105832015
- E-mail: vlambadiari@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
The diagnosis of diabetes mellitus will be established according to the diagnostic criteria defined by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and the European Association for the Study of Obesity (EASO).
Male and/or female patients attending the regular outpatient ophthalmology clinics, with stable refraction over the past two years, without pathological corneal findings (including corneal ulcer, keratoconus, corneal dystrophies, corneal trauma/abrasions), no history of corneal infections during the last 2 years, and no history of refractive surgery will be included.
To ensure the objectivity of the results, the assessment of dry eye disease parameters will be performed by an ophthalmologist blinded to the patient's study group allocation (single-blinded design), thereby minimizing the possibility of observer bias during data collection.
Beschrijving
Inclusion Criteria:
- Age ≥18 years.
- Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).
- Patients able to provide informed consent for participation in the study.
Exclusion Criteria:
- Pregnant or breastfeeding patients.
- History of multiple severe hypoglycemic episodes within the past two years.
- Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
- Patients who have undergone cataract surgery or vitrectomy within the past 6 months.
- History of ketoacidosis or metabolic acidosis.
- History of corneal transplantation.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Group A
50 patients who will receive GLP-1 RAs (Semaglutide) therapy for overweight/obesity, with or without type 2 diabetes mellitus.
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Group B
50 individuals who will be included in the control group and will not receive GLP-1 RA therapy, matched for age, sex, and BMI.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in Ocular Parameters
Tijdsspanne: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
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All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Tear Film Break-Up Time (BUT)
Tijdsspanne: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Change in Tear Film Break-Up Time (BUT): Assessment of changes from baseline in tear film break-up time (BUT), measured in seconds (s), as an indicator of tear film stability and ocular surface function.
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All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Change in Tear Meniscus Height (TMH)
Tijdsspanne: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Change in Tear Meniscus Height (TMH): Assessment of changes from baseline in tear meniscus height (TMH), measured in millimeters (mm), as an indicator of tear volume and ocular surface function.
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All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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Medewerkers en onderzoekers
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Publicaties en nuttige links
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 193-16/02/2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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