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

Primary Purpose

Diabetes Complications

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optical Coherence Tomography Angiography
multidisciplinary care program
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Complications focused on measuring Optical Coherence Tomography Angiography, Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optical Coherence Tomography Angiography

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
May 10, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05645068
Brief Title
Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.
Acronym
OCTACTIPH
Official Title
Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
Optical Coherence Tomography Angiography, Diabetic Macular Edema

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optical Coherence Tomography Angiography
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical Coherence Tomography Angiography
Intervention Description
Optical Coherence Tomography Angiography
Intervention Type
Other
Intervention Name(s)
multidisciplinary care program
Intervention Description
multidisciplinary care program including sports activity
Primary Outcome Measure Information:
Title
coefficient of variation of the superficial retinal capillary plexus
Description
coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3 determinate by OCT Angiography
Time Frame
week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny VARENNE, PH
Phone
05 61 77 11 07
Ext
+33
Email
varenne.f@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny VARENNE, PH
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanny VARENNE, PH
First Name & Middle Initial & Last Name & Degree
Raphaël ADAM
First Name & Middle Initial & Last Name & Degree
Fanny VARENNE, PH
First Name & Middle Initial & Last Name & Degree
Emilie LOBINET, PH
First Name & Middle Initial & Last Name & Degree
Juliette SPIESS, PH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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