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NCT03906383 Clinical Trial

Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03906383
Other study ID # RIK_RVA Diabetes
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2017
Est. completion date October 16, 2018

Study information
Verified date April 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date October 16, 2018
Est. primary completion date October 16, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 31 Years
Eligibility Inclusion Criteria:

- Diabetes type 1

- Diabetic retinopathy

Exclusion Criteria:

- Previous treatment for diabetic retinopathy

- Other ocular and systemic diseases requiring treatment

- Pregnancy or lactation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Remote Ischemic Conditioning
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.

Locations
Country Name City State
Denmark University of Aarhus Aarhus C Danmark

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diameter change of retinal vessels Diameter change from baseline in percent. Immediately after and one hour after
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