We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05645068
Recruitment Status : Not yet recruiting
First Posted : December 9, 2022
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05645068


Contacts
Layout table for location contacts
Contact: Fanny VARENNE, PH 05 61 77 11 07 ext +33 varenne.f@chu-toulouse.fr

Locations
Layout table for location information
France
CHU de Toulouse
Toulouse, France, 31400
Contact: Fanny VARENNE, PH         
Contact: Raphaël ADAM         
Principal Investigator: Fanny VARENNE, PH         
Principal Investigator: Emilie LOBINET, PH         
Sub-Investigator: Juliette SPIESS, PH         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Fanny VARENNE, PH Toulouse University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT05645068    
Other Study ID Numbers: RC31/21/0612
2022-A02003-40 ( Other Identifier: ID-RCB )
First Posted: December 9, 2022    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Optical Coherence Tomography Angiography
Diabetic Macular Edema
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases