Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients Wit… (NCT03594591) | Clinical Trial Compass
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Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes
Spain20 participantsStarted 2018-01-02
Plain-language summary
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.
Who can participate
Age range35 Years – 75 Years
SexALL
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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.
✓. Caucasian and age between 35 and 75 years.
✓. Informed consent by the patient or legal tutor.
Exclusion criteria
✕. Previous history of carotid territory interventionism (stent o endarterectomy).
✕. Presence of carotid plaques in the first centimetre of the posterior wall of the common carotid artery.
✕. Ophtalmologic: Proliferative diabetic retinopathy and/or diabetic macular oedema, retinal photocoagulation, intravitreous therapy and/or vitreo-retinal surgery, myopia of \>6 diopters, history of non-diabetic vascular retinopathy.
✕. Stage 4 chronic kidney disease (estimated glomerular filtration \<30 ml/min/1,73m2), organ transplant, HIV chronic infection, active tuberculosis, active malaria, chronic b or C hepatitis, cirrhosis or intestinal inflammatory disease.
What they're measuring
1
Changes in retinal microcirculation (perifoveal vessel density)
Timeframe: 0, 1, 3 and 6 months
2
Changes in arterial wall microcirculation (vasa-vasorum density)
. Current pregnancy or breastfeeding, o gestational desire in the following two years.
✕. History of alcohol or drug dependence (except for caffeine and nicotine) in the former 5 years, active depression or psychiatric disease, dementia, presence of another chronic or debilitating disease with short life-expectancy, institutionalization or severe disability.
✕. Presence of contraindications for the use of ecographic contrast.
✕. Current Participation in another study protocol.