Back to resultsHuman Vasodilatory Effect of GLP-1
Primary Purpose
Coronary Stenosis, Type2 Diabetes, Angina, Stable
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GLP-1 (7-36)Amide
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Stenosis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline
Change in coronary microcirculatory resistance from baseline
Forearm bloodflow ratio with GLP-1
Peripheral vasodilatory response of GLP-1
Secondary Outcome Measures
Full Information
NCT ID
NCT03502083
First Posted
April 3, 2018
Last Updated
April 10, 2018
Sponsor
Papworth Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03502083
Brief Title
Human Vasodilatory Effect of GLP-1
Official Title
Vasodilatory Effect of GLP-1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Type2 Diabetes, Angina, Stable
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GLP-1 (7-36)Amide
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline
Description
Change in coronary microcirculatory resistance from baseline
Time Frame
Change from baseline
Title
Forearm bloodflow ratio with GLP-1
Description
Peripheral vasodilatory response of GLP-1
Time Frame
Change from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35470686
Citation
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.
Results Reference
derived
PubMed Identifier
33932990
Citation
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.
Results Reference
derived
Learn more about this trial
Human Vasodilatory Effect of GLP-1
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