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

NCT05645068 | Unknown

• 2 other identifiers: RC31/21/06122022-A02003-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Complications

Keywords

Optical Coherence Tomography Angiography; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• coefficient of variation of the superficial retinal capillary plexus

  coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3 determinate by OCT Angiography

  week 3

Study Arms (1)

Optical Coherence Tomography Angiography

EXPERIMENTAL

Diagnostic Test: Optical Coherence Tomography Angiography; Other: multidisciplinary care program

Interventions

Optical Coherence Tomography Angiography DIAGNOSTIC_TEST

Optical Coherence Tomography Angiography

Optical Coherence Tomography Angiography

multidisciplinary care program OTHER

multidisciplinary care program including sports activity

Optical Coherence Tomography Angiography

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 31400, France

RECRUITING

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Fanny VARENNE, PH

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny VARENNE, PH

CONTACT

05 61 77 11 07; varenne.f@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: February 28, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)