| Registry | NCT06995131, acronym DEL-1 and IL-1 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 61 (Actual) |
| Sponsor | Uşak University (Other) |
| Conditions | Cataract |
| Interventions | Observational Study Procedure (Other) |
| Dates | start 2025-05-01, primary completion 2025-10-01, completion 2025-10-15, first posted 2025-05-29, last updated 2026-10-19 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Cataract All trials of Observational Study Procedure
By comparing DEL-1 and IL-17 levels in the aqueous humor of diabetic cataract patients with the aqueous humor of non-diabetic patients, we aim to understand the biochemical effects of diabetes-related inflammatory processes in the eye.
Developmental Endothelial Locus-1 (DEL-1) is a molecule related to endothelial cells and is a protein involved in intercellular interactions. It is generally associated with the development and function of endothelial cells lining the inner surface of the vessel. It plays an important role in the regulation of inflammation, the development of vessels and the organization of endothelial cells. It has also been shown to be associated with some types of cancer. It may also be effective in tissue regeneration and healing of injuries.
IL-17 (Interleukin-17) is a group of cytokines that play an important role in the immune system. There are several subtypes of IL-17, the best known and most researched being IL-17A. It regulates the body's immune response to certain infections. It is an important cytokine that initiates and supports the inflammation process. IL-17 plays an important role in the pathogenesis of various autoimmune and inflammatory diseases.
DEL-1 and IL-17 are two different molecules that act on inflammation and immune responses. DEL-1 helps regulate inflammation by protecting vascular health, while IL-17 can accelerate the course of diseases by increasing inflammation.
Diabetes is a systemic disease associated with oxidative stress and chronic inflammation. Retinopathy, cataract and glaucoma diseases develop due to diabetes. DEL-1 is a protein involved in the maintenance of vascular homeostasis and regulation of inflammation. Since diabetic patients have chronic inflammation and microvascular dysfunction, changes in DEL-1 levels may provide important clues to the pathophysiology
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diabetic Cataract Group | Other: Observational Study Procedure | Patients with type 2 diabetes and cataract without diabetic retinopathy. | |
| Control Group | Other: Observational Study Procedure | Non-diabetic patients undergoing cataract surgery. |
Sex: All, ages: 50 Years to 80 Years, accepts healthy volunteers
Inclusion Criteria: * Cataract diagnosed and surgery planned * Patients without any other ocular pathology other than cataract. * Type 2 DM for at least 5 years in the diabetic group Exclusion Criteria: * Patients with previous intraocular surgery * Those with inflammatory eye diseases (e.g. uveitis) * Those with autoimmune diseases or systemic inflammatory diseases * Those receiving local or systemic steroid therapy * Those with severe systemic disease (e.g. advanced renal failure, malignancy)
| Milestone | Diabetic Cataract Group | Control Group (Non-Diabetic Cataract) |
|---|---|---|
| Started | 33 | 28 |
| Completed | 33 | 28 |
| Not completed | 0 | 0 |
Time frame: Deaths and Adverse Events were not collected as part of this observational biomarker study
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Diabetic Cataract Group | 0 | 0 | 0 |
| Control Group | 0 | 0 | 0 |
Limitations and caveats: This study had a relatively small sample size and was limited to patients undergoing cataract surgery at a single center, which may affect the generalizability of the findings. Additionally, the cross-sectional design precludes assessment of causality or long-term dynamics of DEL-1 and IL-17 levels. The absence of patients with diabetic retinopathy limits the ability to evaluate the role of these markers in advanced ocular inflammation.
| Facility | City | Country | Status |
|---|---|---|---|
| Usak University Training and Research Hospital | Uşak | Turkey (Türkiye) |