HealthyEarly Phase 1NCT02493959
Degradation of the Anorexic Hormone Peptide YY
A Early Phase 1 study testing PYY1-36 infusion, PYY1-36 + sitagliptin and PYY3-36 infusion in people with Healthy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a C-terminally degraded metabolite, PYY3-34, is formed… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PYY1-36 infusion, PYY1-36 + sitagliptin and PYY3-36 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jul 2015
- Phase
- Early Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normal BMI (18.5-25kg/m2)
Who cannot join
- Diabetes Mellitus
- Gastric bypass
- Non-caucasian
- Height changes >3 kg within last two months
- Hemoglobin < 7.6 mmol/l
- Chronic disease
Show all 9Show fewer
- Smoking
- Regularly use of medicine
- Drug abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre Hospital
Hvidovre, DK-2650
About this study
Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.
- Conditions
- Healthy
- Being tested
- PYY1-36 infusion, PYY1-36 + sitagliptin, PYY3-36 infusion, placebo
- Keywords
- PYY, Degradation, kinetics, men
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYY1-36 infusionBiological
Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.
PYY1-36 + sitagliptinBiological
Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.
PYY3-36 infusionBiological
0.8 pmol/kg/min infusion of PYY3-36.
placeboBiological
Infusion of saline for 2 hrs.
| Study group | Role | What they receive |
|---|---|---|
| PYY infusion | Experimental | IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years Receives: Biological: PYY1-36 infusion; Biological: PYY1-36 + sitagliptin; Biological: PYY3-36 infusion; Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PYY3-34 concentration
Measured: 0-240 min
Half-lives of PYY1-36 and PYY3-36
Measured: 0-240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493959
- Sponsor's protocol ID
- STKBM-PI14
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degradation of the Anorexic Hormone Peptide YY
- ClinicalTrials.gov ID
- NCT02493959
- Acronym / sponsor ID
- STKBM-PI14
- Conditions
- Healthy
- Keywords
- PYY, Degradation, kinetics, men
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PYY infusion | Experimental | Biological: PYY1-36 infusion, Biological: PYY1-36 + sitagliptin, Biological: PYY3-36 infusion, Biological: placeboIV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Normal BMI (18.5-25kg/m2)
Key exclusion criteria (9 listed)
- Diabetes Mellitus
- Gastric bypass
- Non-caucasian
- Height changes >3 kg within last two months
- Hemoglobin < 7.6 mmol/l
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 |
|---|---|---|
| PYY1-36 infusionInfusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. | Biological | PYY infusion |
| PYY1-36 + sitagliptinInfusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively. | Biological | PYY infusion |
| PYY3-36 infusion0.8 pmol/kg/min infusion of PYY3-36. | Biological | PYY infusion |
| placeboInfusion of saline for 2 hrs. | Biological | PYY infusion |
Primary outcome
PYY3-34 concentration
Time frame: 0-240 min
Half-lives of PYY1-36 and PYY3-36
Time frame: 0-240 min
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 10 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PYY1-36 infusion, PYY1-36 + sitagliptin and PYY3-36 infusion in people with Healthy, run by Hvidovre University Hospital at 1 site in Denmark.
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 9 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 10 Jul 2015. 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 Denmark. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
PYY3-34 concentration (time frame: 0-240 min). 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?
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 10 Jul 2015.