Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects. (OCTACTIPH)

May 10, 2023 updated by: University Hospital, Toulouse

Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.

Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.

Recently, it has been proven that the parameters measured by Optical Coherence Tomography (OCT) Angiography: the vascular density of the macular retinal capillary plexi and the foveolar avascular zone, can be modified after a high-intensity sports training program in healthy subjects.

the team wants to study the evolution of the macular, in type 2 diabetic subjects, before and after a stay in a care structure dedicated to the multidisciplinary and integrative management (nutrition, physical activity, therapeutic education) of a duration of 3 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevention of vascular and neurological complications in diabetic subjects represents a major public health issue. Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.

Diabetes management is global and aims at a stable glycemic balance putting the patient out of the micro and macrovascular complications linked to this pathology. It involves modifying the lifestyle of patients with the practice of appropriate physical activity, balancing daily food intake, not necessarily by taking insulin-sensitizing or hypoglycemic drug treatment, but also by management of other risk factors related to complications: dyslipidemia, weight, smoking, arterial blood pressure balance.

The use of Optical Coherence Tomography Angiography allow the evaluation of the microvasculature of the macula.

Diabetic macular edema is the leading cause of vision loss in type 2 diabetic subjects mainly due to dysfunction of the macular microvasculature.

Macular analysis via Optical Coherence Tomography Angiography can quickly and non-invasively predict the risk of occurrence of Diabetic macular edema and therefore that of a decrease in acuity and visual impairment.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31400
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • Fanny VARENNE, PH
        • Contact:
          • Raphaël ADAM
        • Principal Investigator:
          • Fanny VARENNE, PH
        • Principal Investigator:
          • Emilie LOBINET, PH
        • Sub-Investigator:
          • Juliette SPIESS, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient for whom a 3-week multidisciplinary and integrative program was offered in a diabetology unit
  • Patient having given his consent
  • Patient affiliated to a social security scheme or equivalent
  • Patient with type 2 diabetes

Exclusion Criteria:

  • History of exudative or tractional retinal detachment
  • Intraocular foreign body
  • History of endophthalmitis
  • History of inflammatory disease of the retina
  • History of chorioretinitis
  • Patient with age-related macular degeneration
  • Patients with type 1 diabetes or secondary diabetes
  • Uncontrolled hypertension does not define Systolic arterial pressure (SAP) > 180 mmHg or Diastolic arterial pressure (DAP) > 110 mmHg
  • Patient who has already received intravitreal injections of anti-angiogenic molecules.
  • Pregnant or breastfeeding patient at the time of the study
  • Persons under a legal protection regime for adults (safeguard of justice, guardianship, curatorship, institutionalized, or under mandate for future protection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optical Coherence Tomography Angiography
Diagnostic test: Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography
Other: multidisciplinary care program
multidisciplinary care program including sports activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coefficient of variation of the superficial retinal capillary plexus
Time Frame: week 3
coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3 determinate by OCT Angiography
week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Fanny VARENNE, PH, Toulouse University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0612
  • 2022-A02003-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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