Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03594591
Recruitment Status : 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

Tracking Information
First Submitted Date May 10, 2018
First Posted Date July 20, 2018
Last Update Posted Date July 24, 2018
Actual Study Start Date January 2, 2018
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2018)
  • 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)
  • 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
Original Primary Outcome Measures
 (submitted: July 13, 2018)
  • 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)
  • Changes in arterial wall microciculation (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
Change History Complete list of historical versions of study NCT03594591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 13, 2018)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes
Official Title Changes in the Retinal and Carotid Microcirculation After Restoring Normoglycemia in Patients With Type 2 Diabetes (OCTAUS-T2D Study)
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Type 2 Diabetes Mellitus
  • Microangiopathy
  • Diabetic Retinopathy
  • Arteriosclerosis
  • Carotid Atherosclerosis
Intervention Drug: Antidiabetic treatment by usual care
Observation of changes in the microcirculation after optimization of antidiabetic therapy by usual care.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emilio Ortega, MD, PhD +34932279846 eortega1@clinic.ub.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03594591
Other Study ID Numbers PI 17/01479
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Emilio Ortega Martínez de Victoria, Hospital Clinic of Barcelona
Study Sponsor Hospital Clinic of Barcelona
Collaborators
  • Instituto de Salud Carlos III
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer
Investigators
Principal Investigator: Emilio Ortega, MD; PhD Hospital Clínic of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date July 2018