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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
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This is a prospective and observational study in patients with type two diabetes. The study hypothesis is that chronic hyperglycemia causes an increase in the microcirculation on the carotid artery wall and retina, evaluated by angio-OCT. Furthermore, the reestablishment of normoglycemia would decrease this microcirculation, which could trigger hypoxic and ischemic changes, accelerating preclinical atherosclerosis. The study goal is to describe the microangiopathy in both territories in patients with type two diabetes and chronic hyperglycemia, and to evaluate changes after the reestablishment of normoglycemia.
This is a prospective and observational study in patients with type two diabetes. The study hypothesis is that chronic hyperglycemia causes an increase in the microcirculation on the carotid artery wall (evaluating vasa vasorum by contrast-assessed carotid ultrasound) and retina (evaluated by angio-OCT). Furthermore, the reestablishment of normoglycemia would decrease this microcirculation, which could trigger hypoxic and ischemic changes, accelerating preclinical atherosclerosis. The primary outcome is to describe the microangiopathy in both territories in 20 patients with type two diabetes and chronic hyperglycemia (basal), and to evaluate the changes after the reestablishment of normoglycemia (at 1, 3 and 6 months). Additionally, clinical, laboratory, diet and biomarkers will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidiabetic treatment by usual care | Drug | Observation of changes in the microcirculation after optimization of antidiabetic therapy by usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in retinal microcirculation (perifoveal vessel density) | Changes in perifoveal vessel density, OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 0, 1, 3 and 6 months |
| Changes in arterial wall microcirculation (vasa-vasorum density) | Changes vasa-vasorum (VV) density, VV signal as the ratio of the contrast agent signal of the VV and that of the lumen of the artery | 0, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in retinal microcirculation (Parafoveal vessel density ) | OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 0, 1, 3 and 6 months |
| Changes in retinal microcirculation (Total Avascular Area ) |
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Inclusion Criteria:
Patients with type two diabetes with chronic hyperglycemia (HbA1c >9%) in who a swift and maintained improvement in glycemic control is expected, as a consequence of the antidiabetic treatment decided by usual care owing to the clinical situation.
This treatment will include, in many cases, albeit not always, insulin (basal, basal-plus, mixes, or multiple doses). The usual clinical scenario will be failure to non-insulin antidiabetic drugs or to combined treatment (basal insulin and non-insulin drugs). Patients with new diagnose of type two diabetes who start treatment (insulin and non-insulin drugs) in which a long-evolution diabetes is suspected will also be candidates.
Caucasian and age between 35 and 75 years.
Informed consent by the patient or legal tutor.
Exclusion Criteria:
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Patients with type two diabetes with chronic hyperglycemia (HbA1c >9%) in who a swift and maintained improvement in glycemic control is expected, as a consequence of the antidiabetic treatment decided by usual care owing to the clinical situation. Patients with new diagnose of type two diabetes who start treatment (insulin and non-insulin drugs) in which a long-evolution diabetes is suspected will also be candidates.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilio Ortega, MD, PhD | Contact | +34932279846 | eortega1@clinic.ub.es |
| Name | Affiliation | Role |
|---|---|---|
| Emilio Ortega, MD; PhD | Hospital Clínic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18539917 | Background | Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6. | |
| 27281772 |
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OCTA images will be processed to obtain total avascular area measurements (mm2)
| 0, 1, 3 and 6 months |
| Changes in retinal microcirculation (Foveal Avascular Area) | OCTA images will be processed to obtain foveal avascular zone area measurements (mm2) | 0, 1, 3 and 6 months |
| Background |
| Sanahuja J, Alonso N, Diez J, Ortega E, Rubinat E, Traveset A, Alcubierre N, Betriu A, Castelblanco E, Hernandez M, Purroy F, Arcidiacono MV, Jurjo C, Fernandez E, Puig-Domingo M, Groop PH, Mauricio D. Increased Burden of Cerebral Small Vessel Disease in Patients With Type 2 Diabetes and Retinopathy. Diabetes Care. 2016 Sep;39(9):1614-20. doi: 10.2337/dc15-2671. Epub 2016 Jun 8. |
| 25889409 | Background | Arcidiacono MV, Rubinat E, Borras M, Betriu A, Trujillano J, Vidal T, Mauricio D, Fernandez E. Left carotid adventitial vasa vasorum signal correlates directly with age and with left carotid intima-media thickness in individuals without atheromatous risk factors. Cardiovasc Ultrasound. 2015 Apr 17;13:20. doi: 10.1186/s12947-015-0014-7. |
| 26033395 | Background | Catalan M, Herreras Z, Pinyol M, Sala-Vila A, Amor AJ, de Groot E, Gilabert R, Ros E, Ortega E. Prevalence by sex of preclinical carotid atherosclerosis in newly diagnosed type 2 diabetes. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):742-8. doi: 10.1016/j.numecd.2015.04.009. Epub 2015 May 7. |
| 28334376 | Background | Dimitrova G, Chihara E, Takahashi H, Amano H, Okazaki K. Author Response: Quantitative Retinal Optical Coherence Tomography Angiography in Patients With Diabetes Without Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 2017 Mar 1;58(3):1767. doi: 10.1167/iovs.17-21706. No abstract available. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003930 | Diabetic Retinopathy |
| D001161 | Arteriosclerosis |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D001157 | Arterial Occlusive Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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