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Идёт набор NCT07605572

Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity

— Наблюдательное Dry Eye Disease (DED) Diabete Mellitus GLP-1 Ocular Surface

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Dry Eye Disease (DED), Diabete Mellitus, GLP-1, Ocular Surface. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
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Обзор

Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.

Подробное описание

This prospective cohort study aims to shed a light to the effects of GLP-1 RAs on Dry Eye Disease in Patients with Type 2 Diabetes Mellitus and Obesity.

Первичные конечные точки

  • Changes in Ocular Parameters [Срок оценки: 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.]
Вторичные конечные точки (2)
  • Change in Tear Film Break-Up Time (BUT) [Срок оценки: 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.]
  • Change in Tear Meniscus Height (TMH) [Срок оценки: 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.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Греция · 1 центр
  • 2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and — Athens

Публикации

  • Yamanishi R, Sawada N, Hanyuda A, Uchino M, Kawashima M, Yuki K, Tsubota K, Kato T, Saito I, Arima K, Mizukami S, Tanno K, Sakata K, Yamagishi K, Iso H, Yasuda N, Shimazu T, Yamaji T, Goto A, Inoue M, Iwasaki M, Tsugane S; JPHC-NEXT Group. Relation Between Body Mass Index and Dry Eye Disease: The Japan Public Health Center-Based Prospective Study for the Next Generation. Eye Contact Lens. 2021 Aug PMID 34310488

Идентификаторы

NCT: NCT07605572 · 193-16/02/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗