Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients
ConditionDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
The prevalence of diabetes is increasing, with type 2 diabetes mellitus comprising over 90% of cases. Diabetes mellitus complications, including diabetic retinopathy (DR), impose significant health burdens. GLP-1 receptor agonists (GLP-1RAs) and dual GIP/GLP-1 receptor agonists show promise in improving cardiovascular and kidney outcomes, but their effects on retinal microvasculature and neuroprotection remain unclear. This study investigates the impact of GLP-1RAs (semaglutide, liraglutide) and GIP/GLP-1-dual agonists (tirzepatide) on ocular blood flow and retinal function in DM patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged ≥ 18 years
Signed informed consent
Previously diagnosed diabetes mellitus
Normal ophthalmic findings except diabetic retinopathy, unless the investigator considers an abnormality to be clinically irrelevant
Disqualifiers
Participation in a clinical trial in the 3 weeks preceding the screening visit
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
Abuse of alcoholic beverages
Trial design
Design model
Single group
Treatments tested in this trial
• Laser Speckle Flowgraphy (LSFG)
DeviceLaser Speckle Flowgraphy (LSFG)
• Optical Coherence Tomography (OCT)
Device• Optical Coherence Tomography (OCT)
• Optical Coherence Tomography Angiography (OCT-A)
Device• Optical Coherence Tomography Angiography (OCT-A)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Diabetes mellitus GLP1-RAExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Ocular blood flow (LSFG)
Ocular Blood Flow measured by Laser Speckle Flowgraphy (LSFG) in arbitrary units
Time frame
From enrollment to last study day (=5-11 weeks)Secondary outcomes
1
Retinal vessel diameter
Retinal vessel diameter with DVA
Time frame
From enrollment to last study day (=5-11 weeks)2
Retinal oxygen saturation
Retinal oxygen saturation with DVA
Time frame
From enrollment to last study day (=5-11 weeks)3
Retinal oxygen extraction
Retinal oxygen extraction will be calculated from measurements of ocular blood flow and retinal oxygen saturation. The calculation will be based on a formula integrating these parameters to estimate retinal oxygen extraction. Unit of Measure: Arbitrary units
Time frame
From enrollment to last study day (=5-11 weeks)4
Oxygen and carbon dioxide partial pressure in arterialized blood
Oxygen and carbon dioxide partial pressure in arterialized blood
Time frame
From enrollment to last study day (=5-11 weeks)Sponsors and contacts
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Source ClinicalTrials.gov