Coronary StenosisNCT03502083
Human Vasodilatory Effect of GLP-1
A study testing GLP-1 (7-36)Amide in people with Coronary Stenosis and Type2 Diabetes, run by Papworth Hospital NHS Foundation Trust.
Trial summary
Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Type2 Diabetes, Angina, Stable
- What is being tested?
- GLP-1 (7-36)Amide
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waiting list for elective PCI to LAD Able to give informed consent Over 18
Who cannot join
- GLP-1 based therapy Insulin Calcium channel blockers Nicorandil Nitrates
About this study
Official title: Vasodilatory Effect of GLP-1
Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries
- Conditions
- Coronary Stenosis, Type2 Diabetes, Angina, Stable
- Being tested
- GLP-1 (7-36)Amide
- Medical subject headings
- Coronary Stenosis, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 (7-36)AmideDrug
IV infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline
Change in coronary microcirculatory resistance from baseline
Measured: Change from baseline
Forearm bloodflow ratio with GLP-1
Peripheral vasodilatory response of GLP-1
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Dec 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502083
- Sponsor's protocol ID
- 14/EE/0018
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35470686Aetesam-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.
PubMed 33932990
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasodilatory Effect of GLP-1
- ClinicalTrials.gov ID
- NCT03502083
- Acronym / sponsor ID
- 14/EE/0018
- Conditions
- Coronary Stenosis, Type2 Diabetes, Angina, Stable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Waiting list for elective PCI to LAD Able to give informed consent Over 18
Key exclusion criteria (1 listed)
- GLP-1 based therapy Insulin Calcium channel blockers Nicorandil Nitrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 (7-36)AmideIV infusion | Drug | – |
Primary outcome
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
Forearm bloodflow ratio with GLP-1
Time frame: Change from baseline
Peripheral vasodilatory response of GLP-1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Derived from this study: PubMed 35470686Aetesam-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.
- Derived from this study: PubMed 33932990Aetesam-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 (7-36)Amide in people with Coronary Stenosis and Type2 Diabetes, run by Papworth Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IMR (index of microcirculatory resistance) with GLP-1 compared with baseline (time frame: Change from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.