Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes

NCT03594591 | Unknown

• 1 other identifier: PI 17/01479
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Microangiopathy; Diabetic Retinopathy; Arteriosclerosis; Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Changes in retinal microcirculation (Parafoveal vessel density )

  0, 1, 3 and 6 months

• Changes in retinal microcirculation (Total Avascular Area )

  0, 1, 3 and 6 months

• Changes in retinal microcirculation (Foveal Avascular Area)

  0, 1, 3 and 6 months

Interventions

Antidiabetic treatment by usual care DRUG

Observation of changes in the microcirculation after optimization of antidiabetic therapy by usual care.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Instituto de Salud Carlos III: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 18539917 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.

  PMID: 27281772 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.

  PMID: 25889409 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.

  PMID: 26033395 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.

  PMID: 28334376 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Retinopathy; Arteriosclerosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Emilio Ortega, MD; PhD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Ortega, MD, PhD

CONTACT

+34932279846; eortega1@clinic.ub.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant Endocrinologist

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 20, 2018
• Study Start: January 2, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

ES (1)