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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes mellitus GLP1-RA | Experimental | Measurements of the Ocular Blood Flow and Retinal Oxygen Extraction are performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • Laser Speckle Flowgraphy (LSFG) | Device | Laser Speckle Flowgraphy (LSFG) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular blood flow (LSFG) | Ocular Blood Flow measured by Laser Speckle Flowgraphy (LSFG) in arbitrary units | From enrollment to last study day (=5-11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal vessel diameter | Retinal vessel diameter with DVA | From enrollment to last study day (=5-11 weeks) |
| Retinal oxygen saturation | Retinal oxygen saturation with DVA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doreen Schmidl, Prof. Priv. Doz. MD.; PhD | Contact | +431404002981 | doreen.schmidl@meduniwien.ac.at | |
| Doreen Schmidl, Prof. Priv. Doz. MD, PhD | Contact | +431404002981 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| • Optical Coherence Tomography (OCT) |
| Device |
• Optical Coherence Tomography (OCT) |
|
| • Optical Coherence Tomography Angiography (OCT-A) | Device | • Optical Coherence Tomography Angiography (OCT-A) |
|
| From enrollment to last study day (=5-11 weeks) |
| 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 | From enrollment to last study day (=5-11 weeks) |
| Oxygen and carbon dioxide partial pressure in arterialized blood | Oxygen and carbon dioxide partial pressure in arterialized blood | From enrollment to last study day (=5-11 weeks) |
| Central retinal thickness | Central retinal thickness with OCT | From enrollment to last study day (=5-11 weeks) |
| Retinal nerve fiber layer thickness | Retinal nerve fiber layer thickness with OCT | From enrollment to last study day (=5-11 weeks) |
| Retinal and choroidal microvasculature | Retinal and choroidal microvasculature with OCT-A | From enrollment to last study day (=5-11 weeks) |
| Capillary blood glucose level | Capillary blood glucose level in mg/dL | From enrollment to last study day (=5-11 weeks) |
| Autonomic and sensomotoric neuropathy measurements | Short-term spectral analysis of Heart rate variability (HRV) is obtained from recordings consisting of 256 seconds of artifact free recordings. Parameters of frequency-domain HRV are measured within the low-frequency band and high-frequency band, as well as total spectral variability. Outcome variables are spectral power (ms2) in both frequency bands as well as cumulative indices. | From enrollment to last study day (=5-11 weeks) |
| Ocular perfusion pressure | Ocular perfusion pressure is calculated from systemic blood pressure and intraocular pressure. Unit of measurement: mmHg | From enrollment to last study day (=5-11 weeks) |
| Intraocular pressure | Intraocular pressure | From enrollment to last study day (=5-11 weeks) |
| Systemic hemodynamics - Blood pressure | Systolic and diastolic blood pressure is measured. Unit: mmHg | From enrollment to last study day (=5-11 weeks) |
| Schirmer I Test | Schirmer I Test is performed. Unit of measuremnt: mm | From enrollment to last study day (=5-11 weeks) |
| Finger sweat sampling | Finger sweat samples will be collected using stamped-out filter paper applied to the fingertip under standardized conditions. Samples will be analyzed using an untargeted multi-omics approach. Proteomic, eicosadomic, and metabolomic profiles will be assessed using high-resolution mass spectrometry platforms. Unit of Measure: Arbitrary units (normalized intensity values) | From enrollment to last study day (=5-11 weeks) |
| Systemic hemodynamics - Heart rate | Heart rate is measured. Unit: Hz | From enrollment to last study day (=5-11 weeks) |
| Systemic hemodynamics - Oxygen saturation | Oxygen saturation is measured. Unit: % | From enrollment to last study day (=5-11 weeks) |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |