Back to resultsChanges in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Primary Purpose
Retinal Ischemia, Diabetes Complications, Ischemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Remote Ischemic Conditioning
Sponsored by
About this trial
This is an interventional basic science trial for Retinal Ischemia
Eligibility Criteria
Inclusion Criteria:
- Diabetes type 1
- Diabetic retinopathy
Exclusion Criteria:
- Previous treatment for diabetic retinopathy
- Other ocular and systemic diseases requiring treatment
- Pregnancy or lactation
Sites / Locations
- University of Aarhus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote Ischemic Conditioning
Arm Description
Outcomes
Primary Outcome Measures
Diameter change of retinal vessels
Diameter change from baseline in percent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03906383
Brief Title
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Official Title
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal ischemic diseases. The purpose of the present study is to examine if the autoregulation of retinal vessel diameters in diabetic patients change after remote ischemic conditioning and if the observations are different from what have been observed in normal persons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Ischemia, Diabetes Complications, Ischemia, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Conditioning
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Remote Ischemic Conditioning
Intervention Description
Brief reversible restriction of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
Primary Outcome Measure Information:
Title
Diameter change of retinal vessels
Description
Diameter change from baseline in percent.
Time Frame
Immediately after and one hour after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes type 1
Diabetic retinopathy
Exclusion Criteria:
Previous treatment for diabetic retinopathy
Other ocular and systemic diseases requiring treatment
Pregnancy or lactation
Facility Information:
Facility Name
University of Aarhus
City
Aarhus C
State/Province
Danmark
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31273510
Citation
El Dabagh Y, Petersen L, Pedersen M, Bek T. Reduced baseline diameter and contraction of peripheral retinal arterioles immediately after remote ischemia in diabetic patients. Graefes Arch Clin Exp Ophthalmol. 2019 Oct;257(10):2095-2101. doi: 10.1007/s00417-019-04407-x. Epub 2019 Jul 4.
Results Reference
derived
Learn more about this trial
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
We'll reach out to this number within 24 hrs