NCT03906383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

April 4, 2019

Last Update Submit

April 12, 2019

Conditions

Retinal IschemiaDiabetes ComplicationsIschemiaDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Diameter change of retinal vessels

    Diameter change from baseline in percent.

    Immediately after and one hour after

Study Arms (1)

Remote Ischemic Conditioning

EXPERIMENTAL
Other: Remote Ischemic Conditioning

Interventions

Remote Ischemic ConditioningOTHER

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.

Remote Ischemic Conditioning

Eligibility Criteria

Age20 Years - 31 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes type 1
  • Diabetic retinopathy

You may not qualify if:

  • Previous treatment for diabetic retinopathy
  • Other ocular and systemic diseases requiring treatment
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aarhus

Aarhus C, Danmark, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 31273510DERIVED

MeSH Terms

Conditions

Diabetes ComplicationsIschemiaDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

November 21, 2017

Primary Completion

October 16, 2018

Study Completion

October 16, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

DK(1)