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AzTrials

Type 2 Diabetes MellitusOCTAUS-T2DNCT03594591

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

An observational study of Type 2 Diabetes Mellitus and Microangiopathy, run by Hospital Clinic of Barcelona at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years
How many people
20 participants
Where
1 siteSpain
Study dates
2 Jan 2018to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Emilio Ortega, MD, PhD contact

+34932279846

eortega1@clinic.ub.es

Spain1 site, 1 recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036

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

    Antonio J Amor, MD

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Antidiabetic treatment by usual care
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Retinopathy, Arteriosclerosis, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antidiabetic treatment by usual careDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 0, 1, 3 and 6 months

  2. 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

    Measured: 0, 3 and 6 months

Secondary outcomes (3)

  1. Changes in retinal microcirculation (Parafoveal vessel density )

    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

    Measured: 0, 1, 3 and 6 months

  2. Changes in retinal microcirculation (Total Avascular Area )

    OCTA images will be processed to obtain total avascular area measurements (mm2)

    Measured: 0, 1, 3 and 6 months

  3. Changes in retinal microcirculation (Foveal Avascular Area)

    OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)

    Measured: 0, 1, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start2 Jan 2018
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594591
Sponsor's protocol ID
PI 17/01479
Acronym
OCTAUS-T2D
Status last verified
Jul 2018
First submitted
10 May 2018
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18539917

  • 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.

    PubMed 27281772

  • 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.

    PubMed 25889409

  • 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.

    PubMed 26033395

  • 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.

    PubMed 28334376

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and Microangiopathy, run by Hospital Clinic of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emilio Ortega, MD, PhD (+34932279846, eortega1@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in retinal microcirculation (perifoveal vessel density) (time frame: 0, 1, 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594591, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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