NCT02746757

Brief Summary

The study was designed to investigate whether glucagon like peptide-1 is a mediator of protection of endothelial function induced by remote ischemic conditioning in ischemia-reperfusion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable healthy-volunteers

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

May 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

April 18, 2016

Last Update Submit

March 5, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Change in endothelium dependent vasodilatation

    20 min post-reperfusion

Study Arms (3)

Ischemia-reperfusion no intervention

NO INTERVENTION

Ischemia-reperfusion without intervention

Ischemia-reperfusion with RIPC

EXPERIMENTAL

Ischemia-reperfusion with intervention by RIPC

Other: Remote conditioning

Ischemia-reperfusion with RIPC and Ex 9-39

EXPERIMENTAL

Ischemia-reperfusion with RIPC and Ex 9-39

Other: Remote conditioningDrug: Exendin 9-39

Interventions

Remote conditioningOTHER
Ischemia-reperfusion with RIPCIschemia-reperfusion with RIPC and Ex 9-39
Exendin 9-39DRUG
Ischemia-reperfusion with RIPC and Ex 9-39

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Interventions

exendin (9-39)

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

SE(1)