HealthyPhase 4NCT03160261
Effect of Exenatide on Cortisol Secretion
A Phase 4 study testing Exenatide Injection in people with Healthy, run by University of Tartu at 1 site in Estonia.
Trial summary
The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exenatide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEstonia
- Study dates
- 7 Sep 2017to 28 Dec 2017
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- Body weight >65 kg
Who cannot join
- Presence of chronic illness
- daily use of any medicines
- pregnancy, lactation
- use of oral contraceptives during previous 2 months
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.
Read the detailed description
Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.
The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.
The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.
- Conditions
- Healthy
- Being tested
- Exenatide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide InjectionDrug
Single injection of Exenatide 10μg subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Single injection of 10 μg Exenatide subcutaneously. Receives: Drug: Exenatide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol peak
Maximum concentration achieved after exenatide dose (any timepoint after injection)
Measured: every 30 minutes during 2 hours after injection
Secondary outcomes (3)
Adrenocorticotropin (ACTH) peak
Maximum concentration achieved after exenatide dose (any timepoint after injection)
Measured: every 30 minutes during 2 hours after injection
Glucose
Glucose values' area under the curve
Measured: Glucose measured every 30 minutes during 2 hours after injection
Growth hormone
Maximum concentration achieved after exenatide dose (any timepoint after injection)
Measured: every 30 minutes during 2 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start7 Sep 2017
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, open-label
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD,PhD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160261
- Sponsor's protocol ID
- Ex17
- Status last verified
- May 2018
- First submitted
- 24 Apr 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.
PubMed 36800161
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exenatide on Cortisol Secretion
- ClinicalTrials.gov ID
- NCT03160261
- Acronym / sponsor ID
- Ex17
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 19 May 2017 (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 primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.
Detailed description
Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.
The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.
The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, open-label
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatide InjectionSingle injection of 10 μg Exenatide subcutaneously. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years
- Body weight >65 kg
Key exclusion criteria (4 listed)
- Presence of chronic illness
- daily use of any medicines
- pregnancy, lactation
- use of oral contraceptives during previous 2 months
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 |
|---|---|---|
| Exenatide InjectionSingle injection of Exenatide 10μg subcutaneously | Drug | Exenatide |
Primary outcome
Cortisol peak
Time frame: every 30 minutes during 2 hours after injection
Maximum concentration achieved after exenatide dose (any timepoint after injection)
3 secondary outcomes
Adrenocorticotropin (ACTH) peak
Time frame: every 30 minutes during 2 hours after injection
Glucose
Time frame: Glucose measured every 30 minutes during 2 hours after injection
Growth hormone
Time frame: every 30 minutes during 2 hours after injection
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 May 2018.
- Derived from this study: PubMed 36800161Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.
- Individual participant dataSharing planned: No
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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.
Vallo Volke, MD,PhD principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide Injection in people with Healthy, run by University of Tartu at 1 site in Estonia.
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 2 inclusion and 4 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 May 2018. 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 Estonia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cortisol peak (time frame: every 30 minutes during 2 hours after injection). 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 NCT03160261, which also lists 1 linked publication.
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 May 2018.