Cardiovascular DiseasesCOCOANCT03835013
Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers
A study testing Saline 0.9%, Glucagon (25ng/kg/min) and Glucagon (50ng/kg/min) in people with Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study seeks to explore the cardiovascular effects of co-agonism at two peptide receptors, GLP-1 and glucagon. Glucagon, exenatide and 0.9% saline will be intravenously infused, both in isolation, and combination into healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Saline 0.9%, Glucagon (25ng/kg/min) and Glucagon (50ng/kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Feb 2019to 1 Nov 2021
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent to participate
- Aged 18 to 40
- Male
- Current non-smoker
- BMI >18.0 and <30kg/m2
Who cannot join
- Female
- Sustained Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
- Clinically significant heart disease
- Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
- Known renal failure (creatinine >140μmol/L)
Show all 11Show fewer
- Known diabetes mellitus (type 1 or 2)
- Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
- Use of formal anticoagulant therapy such as, but not limited to, heparin, warfarin or rivaroxaban
- Current involvement in the active treatment phase of other research studies, (excluding observations/noninterventional)
- Any other clinical reason which may preclude entry in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: A Comparison of the Haemodynamic and Metabolic Effects of Intravenous Glucagon-like Peptide-1, Glucagon and Glucagon-like Peptide-1:Glucagon Co-agonism in Healthy Male Participants
The study seeks to explore the cardiovascular effects of co-agonism at two peptide receptors, GLP-1 and glucagon. Glucagon, exenatide and 0.9% saline will be intravenously infused, both in isolation, and combination into healthy male participants. Overall, the aim of the study is to further our understanding on the role these endogenous substances play (both in isolation and combination) in haemodynamic regulation.
Read the detailed description
Co-agonist peptides (such as at the GLP-1:glucagon receptor) are currently in clinical development for type 2 diabetes with the dual intention of reducing body weight and controlling blood glucose. However, there is a lack of data on the effects that co-agonism has on haemodynamic regulation.
Part A - Healthy male participants, by acting as their own control, will attend for two intravenous infusion visits (combination of 0.9% saline and glucagon). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 120 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study. It was previously planned that GLP-1 7-36 amide 0.6pmol/kg/min and 1.2pmol/kg/min would be infused for Part A resulting in 5 infusions (rather than current 2 infusions). However due to supply/technical issues this was not possible and therefore exenatide (GLP-1 receptor agonist) shall be used in Part B.
Part B - Healthy male participants, by acting as their own control, will attend for four intravenous infusion visits (combination of 0.9% saline, glucagon, exenatide). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 60 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study.
- Conditions
- Cardiovascular Diseases
- Being tested
- Saline 0.9%, Glucagon (25ng/kg/min), Glucagon (50ng/kg/min), Exenatide
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline 0.9%Drug
Also called Placebo
Intravenous infusion of 0.9% saline
Glucagon (25ng/kg/min)Drug
Also called Glucagon
Intravenous infusion of glucagon 25ng/kg/min
Glucagon (50ng/kg/min)Drug
Also called Glucagon
Intravenous infusion of glucagon 50ng/kg/min
ExenatideDrug
Intravenous infusion of Exenatide (loading 50ng/min for 30 minutes followed by 25ng/min for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Part A - Infusion A | Placebo comparator | 1. 60 minute intravenous infusion of 0.9% saline
Followed by:
2. 60 minute intravenous infusion of 0.9% saline Receives: Drug: Saline 0.9% |
| Part A - Infusion B | Active comparator | 1. 60 minute intravenous infusion of glucagon 25ng/kg/min and 0.9% saline.
Followed by:
2. 60 minute infusion of glucagon 50ng/kg/min and 0.9% saline Receives: Drug: Saline 0.9%; Drug: Glucagon (25ng/kg/min); Drug: Glucagon (50ng/kg/min) |
| Part B - Infusion A | Active comparator | A 60 minute intravenous infusion of 0.9% saline Receives: Drug: Saline 0.9% |
| Part B - Infusion B | Active comparator | A 60 minute intravenous infusion of exenatide (50ng/min for 30 minutes followed by 25ng/min) and 0.9% saline Receives: Drug: Saline 0.9%; Drug: Exenatide |
| Part B - Infusion C | Active comparator | A 60 minute intravenous infusion of glucagon (25ng/kg/min) and 0.9% saline Receives: Drug: Saline 0.9%; Drug: Glucagon (25ng/kg/min) |
| Part B - Infusion D | Active comparator | A 60 minute intravenous infusion of exenatide (50ng/min for 30 minutes then 25ng/min) and glucagon (25ng/kg/min) Receives: Drug: Glucagon (25ng/kg/min); Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Heart rate (bpm)
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Brachial systolic and diastolic blood pressure (mmHg)
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Central systolic and diastolic blood pressure and mean arterial pressure (mmHg) measured with SphygmoCor XCEL
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Stroke volume (ml) measured by bioimpedance
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Cardiac output (L/min) measured by bioimpedance
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
peripheral vascular resistance (dynes/sec/cm)
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Heart rate variability (normalised low frequency, LF, high frequency, HF and LF/HF ratio)
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Secondary outcomes (7)
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Glucose, in mmol/L
Measured: Comparison between 2 hour infusion visit 1-5 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
C-peptide, in pmol/L
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Glucagon, in pg/ml
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Insulin, in pmol/L
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Free fatty acids, in μmol/L
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Total GLP-1 and total active GLP-1, in pg/ml
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Gastric inhibitory polypeptide, in pg/ml
Measured: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start11 Feb 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A - 2 infusions Part B - 4 infusions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ian Wilkinson, MA DM FRCP, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835013
- Sponsor's protocol ID
- COCOA
- Other IDs
- 18/EM/0417, 250402
- Acronym
- COCOA
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Haemodynamic and Metabolic Effects of Intravenous Glucagon-like Peptide-1, Glucagon and Glucagon-like Peptide-1:Glucagon Co-agonism in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03835013
- Acronym / sponsor ID
- COCOA / COCOA
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Feb 2019 (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.
The study seeks to explore the cardiovascular effects of co-agonism at two peptide receptors, GLP-1 and glucagon. Glucagon, exenatide and 0.9% saline will be intravenously infused, both in isolation, and combination into healthy male participants. Overall, the aim of the study is to further our understanding on the role these endogenous substances play (both in isolation and combination) in haemodynamic regulation.
Detailed description
Co-agonist peptides (such as at the GLP-1:glucagon receptor) are currently in clinical development for type 2 diabetes with the dual intention of reducing body weight and controlling blood glucose. However, there is a lack of data on the effects that co-agonism has on haemodynamic regulation.
Part A - Healthy male participants, by acting as their own control, will attend for two intravenous infusion visits (combination of 0.9% saline and glucagon). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 120 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study. It was previously planned that GLP-1 7-36 amide 0.6pmol/kg/min and 1.2pmol/kg/min would be infused for Part A resulting in 5 infusions (rather than current 2 infusions). However due to supply/technical issues this was not possible and therefore exenatide (GLP-1 receptor agonist) shall be used in Part B.
Part B - Healthy male participants, by acting as their own control, will attend for four intravenous infusion visits (combination of 0.9% saline, glucagon, exenatide). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 60 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Part A - 2 infusions Part B - 4 infusions
| Arm | Type | Receives |
|---|---|---|
| Part A - Infusion A | Placebo comparator | Drug: Saline 0.9%1. 60 minute intravenous infusion of 0.9% saline Followed by: 2. 60 minute intravenous infusion of 0.9% saline |
| Part A - Infusion B | Active comparator | Drug: Saline 0.9%, Drug: Glucagon (25ng/kg/min), Drug: Glucagon (50ng/kg/min)1. 60 minute intravenous infusion of glucagon 25ng/kg/min and 0.9% saline. Followed by: 2. 60 minute infusion of glucagon 50ng/kg/min and 0.9% saline |
| Part B - Infusion A | Active comparator | Drug: Saline 0.9%A 60 minute intravenous infusion of 0.9% saline |
| Part B - Infusion B | Active comparator | Drug: Saline 0.9%, Drug: ExenatideA 60 minute intravenous infusion of exenatide (50ng/min for 30 minutes followed by 25ng/min) and 0.9% saline |
| Part B - Infusion C | Active comparator | Drug: Saline 0.9%, Drug: Glucagon (25ng/kg/min)A 60 minute intravenous infusion of glucagon (25ng/kg/min) and 0.9% saline |
| Part B - Infusion D | Active comparator | Drug: Glucagon (25ng/kg/min), Drug: ExenatideA 60 minute intravenous infusion of exenatide (50ng/min for 30 minutes then 25ng/min) and glucagon (25ng/kg/min) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent to participate
- Aged 18 to 40
- Male
- Current non-smoker
- BMI >18.0 and <30kg/m2
Key exclusion criteria (11 listed)
- Female
- Sustained Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
- Clinically significant heart disease
- Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
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 |
|---|---|---|
| Saline 0.9%Also: PlaceboIntravenous infusion of 0.9% saline | Drug | Part A - Infusion A, Part A - Infusion B, Part B - Infusion A, Part B - Infusion B, Part B - Infusion C |
| Glucagon (25ng/kg/min)Also: GlucagonIntravenous infusion of glucagon 25ng/kg/min | Drug | Part A - Infusion B, Part B - Infusion C, Part B - Infusion D |
| Glucagon (50ng/kg/min)Also: GlucagonIntravenous infusion of glucagon 50ng/kg/min | Drug | Part A - Infusion B |
| ExenatideIntravenous infusion of Exenatide (loading 50ng/min for 30 minutes followed by 25ng/min for 30 minutes | Drug | Part B - Infusion B, Part B - Infusion D |
Primary outcome
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Heart rate (bpm)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Brachial systolic and diastolic blood pressure (mmHg)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Central systolic and diastolic blood pressure and mean arterial pressure (mmHg) measured with SphygmoCor XCEL
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Stroke volume (ml) measured by bioimpedance
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Cardiac output (L/min) measured by bioimpedance
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
peripheral vascular resistance (dynes/sec/cm)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Heart rate variability (normalised low frequency, LF, high frequency, HF and LF/HF ratio)
7 secondary outcomes
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-5 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
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 3 Apr 2024.
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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.
Ian Wilkinson, MA DM FRCP principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline 0.9%, Glucagon (25ng/kg/min) and Glucagon (50ng/kg/min) in people with Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 11 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination. (time frame: Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.