Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

NCT04888598 | Unknown

• 1 other identifier: IIBSP-RET-2020-69
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.

Conditions

Type 1 Diabetes; Diabetic Retinopathy

Keywords

OCT-A; OCT Angiography

Outcome Measures

Primary Outcomes (1)

• Vessel density

  Density of retinal vessels and perfusion in the macula

  3 months

Secondary Outcomes (1)

• Vessel density

  6 months

Study Arms (1)

Type 1 diabetic patients

Recently diagnosed type 1 diabetes patients

Diagnostic Test: Optical Coherence Tomography (OCT) Angiography

Interventions

Optical Coherence Tomography (OCT) Angiography DIAGNOSTIC_TEST

Measurement of retinal vessel density and distribution in the macula using new generation OCT device

Type 1 diabetic patients

Eligibility Criteria

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

Study Population

Patients diagnosed with type 1 diabetes who meet all the inclusion criteria and none of the exclusion criteria

You may qualify if:

• Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis)
• Age equal to or greater than 18 years
• Signature of the informed consent by the patient / legal guardian.

You may not qualify if:

• Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value \<1 mmol / L).
• Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment
• Previous diagnosis of hypertension and any previous hypotensive treatment
• Previous diagnosis of any form of cardiovascular disease, including heart failure.
• Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate \<60 ml / min)
• Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.)
• History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by "IOL Master" biometry-, neovascular membrane, choroidal tumors, etc.)
• History of posterior uveitis or retinal vasculitis
• Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures.
• Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation
• Dementia or intellectual disability that prevent proper collaboration when acquiring images

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Hospital Arnau de Vilanova: collaborator

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Related Publications (5)

• Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.

  PMID: 22301125 BACKGROUND

• Garg S, Davis R. Diabetic Retinopathy Screening Update. Clinical Diabetes. 2009;27(4):140-145. doi:10.2337/diaclin.27.4.140

  BACKGROUND

• van Hecke MV, Dekker JM, Stehouwer CD, Polak BC, Fuller JH, Sjolie AK, Kofinis A, Rottiers R, Porta M, Chaturvedi N; EURODIAB prospective complications study. Diabetic retinopathy is associated with mortality and cardiovascular disease incidence: the EURODIAB prospective complications study. Diabetes Care. 2005 Jun;28(6):1383-9. doi: 10.2337/diacare.28.6.1383.

  PMID: 15920056 BACKGROUND

• Rodrigues TM, Marques JP, Soares M, Simao S, Melo P, Martins A, Figueira J, Murta JN, Silva R. Macular OCT-angiography parameters to predict the clinical stage of nonproliferative diabetic retinopathy: an exploratory analysis. Eye (Lond). 2019 Aug;33(8):1240-1247. doi: 10.1038/s41433-019-0401-7. Epub 2019 Mar 22.

  PMID: 30903092 BACKGROUND

• Dimitrova G, Chihara E, Takahashi H, Amano H, Okazaki K. Quantitative Retinal Optical Coherence Tomography Angiography in Patients With Diabetes Without Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):190-196. doi: 10.1167/iovs.16-20531.

  PMID: 28114579 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy

Interventions

Tomography, Optical Coherence; Angiography

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Radiography; Diagnostic Techniques, Cardiovascular

Study Officials

• Ignacio Salvador, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Salvador, MD

CONTACT

+34 93 553 74 90; isalvador@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

ES (2)