- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03502083
Human Vasodilatory Effect of GLP-1
April 10, 2018 updated by: Papworth Hospital NHS Foundation Trust
Vasodilatory Effect of GLP-1
Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Waiting list for elective PCI to LAD Able to give informed consent Over 18
Exclusion Criteria:
- GLP-1 based therapy Insulin Calcium channel blockers Nicorandil Nitrates
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline
Time Frame: Change from baseline
|
Change in coronary microcirculatory resistance from baseline
|
Change from baseline
|
|
Forearm bloodflow ratio with GLP-1
Time Frame: Change from baseline
|
Peripheral vasodilatory response of GLP-1
|
Change from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Khialani B, Kyranis S, Braganza DM, Clarke SC, Bennett MR, West NEJ, Hoole SP. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios. J Am Heart Assoc. 2022 May 3;11(9):e023554. doi: 10.1161/JAHA.121.023554. Epub 2022 Apr 26.
- Aetesam-Ur-Rahman M, Giblett JP, Khialani B, Kyranis S, Clarke SJ, Zhao TX, Braganza DM, Clarke SC, West NEJ, Bennett MR, Hoole SP. GLP-1 vasodilatation in humans with coronary artery disease is not adenosine mediated. BMC Cardiovasc Disord. 2021 May 1;21(1):223. doi: 10.1186/s12872-021-02030-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 18, 2018
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/EE/0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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