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Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes (OCTAUS-T2D)

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ClinicalTrials.gov Identifier: NCT03594591
Recruitment Status : Unknown
Verified July 2018 by Emilio Ortega Martínez de Victoria, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : July 20, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Information provided by (Responsible Party):
Emilio Ortega Martínez de Victoria, Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Microangiopathy Diabetic Retinopathy Arteriosclerosis Carotid Atherosclerosis Drug: Antidiabetic treatment by usual care

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes (OCTAUS-T2D Study)
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Antidiabetic treatment by usual care
    Observation of changes in the microcirculation after optimization of antidiabetic therapy by usual care.

Outcome Measures
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Primary Outcome Measures :
  1. Changes in retinal microcirculation (perifoveal vessel density) [ Time Frame: 0, 1, 3 and 6 months ]
    Changes in perifoveal vessel density, OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

  2. Changes in arterial wall microcirculation (vasa-vasorum density) [ Time Frame: 0, 3 and 6 months ]
    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


Secondary Outcome Measures :
  1. Changes in retinal microcirculation (Parafoveal vessel density ) [ Time Frame: 0, 1, 3 and 6 months ]
    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

  2. Changes in retinal microcirculation (Total Avascular Area ) [ Time Frame: 0, 1, 3 and 6 months ]
    OCTA images will be processed to obtain total avascular area measurements (mm2)

  3. Changes in retinal microcirculation (Foveal Avascular Area) [ Time Frame: 0, 1, 3 and 6 months ]
    OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. 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.

  2. Caucasian and age between 35 and 75 years.
  3. Informed consent by the patient or legal tutor.

Exclusion Criteria:

  1. Previous history of carotid territory interventionism (stent o endarterectomy).
  2. Presence of carotid plaques in the first centimetre of the posterior wall of the common carotid artery.
  3. 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.
  4. 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.
  5. Current pregnancy or breastfeeding, o gestational desire in the following two years.
  6. 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.
  7. Presence of contraindications for the use of ecographic contrast.
  8. Current Participation in another study protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594591


Contacts
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Contact: Emilio Ortega, MD, PhD +34932279846 eortega1@clinic.ub.es

Locations
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Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Emilio Ortega, MD, PhD    +34932279846    eortega1@clinic.ub.es   
Sub-Investigator: Antonio J Amor, MD         
Sub-Investigator: Marc Figueras, MD         
Sub-Investigator: Rosa Gilabert, MD, PhD         
Sub-Investigator: Montserrat Cofán, PhD         
Sub-Investigator: Laura Boswell, MD         
Sub-Investigator: Mireia Hereu         
Sub-Investigator: Aleix Sala-Vila, PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Investigators
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Principal Investigator: Emilio Ortega, MD; PhD Hospital Clínic of Barcelona
More Information
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Publications:

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Responsible Party: Emilio Ortega Martínez de Victoria, Principal Investigator, Consultant Endocrinologist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03594591    
Other Study ID Numbers: PI 17/01479
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Artery Diseases
Diabetic Retinopathy
Atherosclerosis
Arteriosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Diabetes Complications
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs