OCTACTIPH: Retinal Microvasculature by OCT Angiography During Integrating Physical Activity in Type 2 Diabetic Subjects.

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05645068

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications	Diagnostic Test: Optical Coherence Tomography Angiography Other: multidisciplinary care program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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.

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

coefficient of variation of the superficial retinal capillary plexus [week 3]
coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient for whom a 3-week multidisciplinary and integrative program was offered in the Diabetology unit of the SSR la Fontaine Salée in Salies du Salat
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 PAS > 180 mmHg or PAD > 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Toulouse	Toulouse		France	31400

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Fanny VARENNE, PH, Toulouse University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT05645068

Other Study ID Numbers:

RC31/21/0612
2022-A02003-40

First Posted:

Dec 9, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Optical Coherence Tomography Angiography

Diabetic Macular Edema

Additional relevant MeSH terms:

Diabetes Complications

Study Results

No Results Posted as of Dec 9, 2022