Glycemic Velocity and Early Retinal Microvascular Change With GLP-1RA Versus SGLT2i Initiation in Type 2 Diabetes (GLIDE)
Starting soon
Conditions studied: Type 2 Diabetes Mellitus, Diabetic Retinopathy (DR)
In brief
The GLIDE study looks at how the small blood vessels of the eye respond during the first months of a new diabetes medicine. Two widely used classes of glucose-lowering drugs, GLP-1 receptor agonists and SGLT2 inhibitors, are compared in adults with type 2 diabetes who have no diabetic retinopathy or only early (mild) diabetic retinopathy. When blood sugar (HbA1c) falls quickly after starting treatment, the retina can undergo a brief, temporary worsening before it stabilizes and benefits over the long term. This study asks whether it is the speed of that blood-sugar reduction, which we call "glycemic velocity," rather than the specific drug, that drives early changes in retinal and choroidal blood flow. Participants are patients whose own physician has decided, independently of the study, to start one of these two drugs for the first time. The study does not choose, provide, or change any medicine; it adds only eye imaging, blood tests, and observation. Each participant is followed with specialized, non-invasive eye scans, optical coherence tomography angiography (OCT-A) and structural/choroidal OCT, together with HbA1c and other measurements, at the start of treatment and again over the following months. The main measurement is the change, from the start of treatment to month 3, in the density of the tiny deep-layer capillaries at the center of the retina, measured on OCT-A. The study will test whether faster HbA1c reduction is linked to greater early change in these vessels and, using statistical mediation analysis, will estimate how much of any difference between the two drug groups is explained by glycemic velocity versus a direct drug effect. If glycemic velocity, a factor physicians can influence by adjusting how quickly treatment is intensified, turns out to drive early retinal change, the findings could guide safer treatment strategies and help identify patients who need closer eye monitoring when starting these medicines.
Key facts
- Study ID
- NCT07723820
- Run by
- Thammasart University Hospital
- People needed
- 126
- Starts
- 2026-09-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 years or older with a documented diagnosis of type 2 diabetes mellitus.
- Clinical decision, made by the treating physician independently of the study, to initiate a first-ever GLP-1 receptor agonist or a first-ever SGLT2 inhibitor.
- Baseline retinal status ranging from no diabetic retinopathy to mild non-proliferative diabetic retinopathy (NPDR) in the study eye(s), confirmed by fundus photography / ETDRS grading.
- Baseline HbA1c within a range permitting a measurable subsequent change (e.g., 7.0% or higher), obtained within 30 days before or after the scheduled ophthalmic assessment.
- Media sufficiently clear and fixation adequate to obtain gradable OCT-A and OCT images.
- Able and willing to provide written informed consent and to attend scheduled follow-up visits.
You may not qualify if…
- Moderate-to-severe NPDR, proliferative diabetic retinopathy, or center-involving diabetic macular edema at baseline.
- Prior or concurrent treatment for diabetic retinopathy or maculopathy: pan-retinal or focal/grid laser photocoagulation, intravitreal anti-VEGF or corticosteroid therapy, or vitreoretinal surgery.
- Any prior exposure to a GLP-1 receptor agonist or SGLT2 inhibitor (to preserve the new-user design).
- Type 1 diabetes, latent autoimmune diabetes of adults, or secondary diabetes.
- Other retinal or choroidal disease that would confound microvascular/choroidal measurement: age-related macular degeneration, retinal vein or artery occlusion, uveitis, high myopia (spherical equivalent more negative than -6.0 D or axial length greater than 26.0 mm), or significant media opacity precluding imaging.
- Coexisting glaucoma or optic neuropathy that independently alters retinal vascular or neural metrics.
- Recent (within 3 months) intraocular surgery in the study eye, including cataract surgery.
- Uncontrolled systemic hypertension or a known systemic condition (e.g., significant anemia, severe renal impairment with eGFR < 30 mL/min/1.73 m², or active malignancy) that independently affects retinal perfusion or oximetry, at investigator discretion.
- Pregnancy, or planned simultaneous initiation of insulin such that the index glucose-lowering exposure cannot be attributed (concurrent stable insulin is permitted and recorded as a pre-specified effect modifier).
- Inability to provide informed consent or to comply with the imaging and follow-up schedule.
Where it is running
- Faculty of Medicine, Thammasat University — Pathum Thani, Khlong Luang, Thailand
Full record on ClinicalTrials.gov
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