NCT03502083

Brief Summary

Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

April 3, 2018

Last Update Submit

April 10, 2018

Conditions

Coronary StenosisType2 DiabetesAngina, Stable

Outcome Measures

Primary Outcomes (2)

  • Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline

    Change in coronary microcirculatory resistance from baseline

    Change from baseline

  • Forearm bloodflow ratio with GLP-1

    Peripheral vasodilatory response of GLP-1

    Change from baseline

Interventions

GLP-1 (7-36)AmideDRUG

IV infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Waiting list for elective PCI to LAD Able to give informed consent Over 18

You may not qualify if:

  • GLP-1 based therapy Insulin Calcium channel blockers Nicorandil Nitrates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 35470686DERIVED

  • 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.

    PMID: 33932990DERIVED

MeSH Terms

Conditions

Coronary StenosisAngina, Stable

Interventions

glucagon-like peptide 1 (7-36)amide

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 18, 2018

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04