Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25+
SponsorSara A Belal

About this trial

This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including metformin) only. Early intervention is critical, as treatment options for advanced stages of DR are limited in terms of their ability to restore impaired vision and their high associated costs. By focusing on delaying the occurrence of diabetic retinopathy, the investigators aim to reduce the burden of DR and improve the quality of life for diabetic patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Type 2 Diabetes for >5 years

Using Diabetes medications (metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors) for a period of 2-3 years

Disqualifiers

Gestational Diabetes

Type 1 Diabetes

Severe non-proliferative diabetic retinopathy (NPDR) at baseline

Proliferative diabetic retinopathy (PDR) at baseline

Trial population

Patients are recruited from Ophthalmology and Diabetes clinics from Alexandria University Main Hospitals.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: Classical Oral Anti-Diabetic Drugs
Group B: New-generation Oral Antidiabetic Drugs

Trial outcomes

Primary outcomes

1

The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).

Where 0 indicates no apparent diabetic retinopathy and 4 indicates proliferative diabetic retinopathy; higher scores indicate more severe (worse) diabetic retinopathy.

Time frame
Assessed once per participant at baseline.

Secondary outcomes

1

Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.

Time frame
Assessed once per participant at baseline.
2

Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.

Time frame
Assessed once per participant at baseline.
3

Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.

Time frame
Assessed once per participant at baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara A Belal

Lead sponsor

Alexandria University

Sponsor institution