HealthyKS-2NCT03573934
Gut Hormones and Bone Remodeling in Humans (KS-2)
A study testing GLP-2, GIP and GLP-2+GIP in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Effects of GLP-2 and GIP on bone remodeling in healthy young men. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLP-2, GIP and GLP-2+GIP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2017to 15 Mar 2018
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.
Who cannot join
- Chronic disease Smoking Medication Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<8,0 mmol/L Decreased renal function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of GLP-2 Mechanism of Action (KS-2)
Effects of GLP-2 and GIP on bone remodeling in healthy young men.
Read the detailed description
We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.
- Conditions
- Healthy
- Being tested
- GLP-2, GIP, GLP-2+GIP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-2Other
GLP-2
GIPOther
GIP
GLP-2+GIPOther
GLP-2+GIP
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GLP-2 | Experimental | Glucagon-Like Peptide-2 (GLP-2) injection Receives: Other: GLP-2 |
| GIP | Experimental | Glucose-dependent Insulinotropic polypeptide (GIP) injection Receives: Other: GIP |
| GLP-2+GIP | Experimental | GLP-2+GIP injection Receives: Other: GLP-2+GIP |
| Placebo | Placebo comparator | Placebo injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone resorption
C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.
Measured: From -10 minutes to 240 minutes.
Bone formation
P1NP is a marker of bone formation. Measured in serum.
Measured: From -10 minutes to 240 minutes.
Secondary outcomes (8)
Parathyroid hormone
PTH is a bone marker
Measured: From -10 minutes to 240 minutes.
Calcium
Measured in serum.
Measured: From -10 minutes to 240 minutes.
GIP
Intact and total GIP.
Measured: From -10 minutes to 240 minutes.
GLP-2
Intact GLP-2
Measured: From -10 minutes to 240 minutes.
Glucose
Measured in serum.
Measured: From -10 minutes to 240 minutes.
Insulin
Measured in serum.
Measured: From -10 minutes to 240 minutes.
C-peptide
Measured in serum.
Measured: From -10 minutes to 240 minutes.
Sclerostin
Bone marker.
Measured: From -10 minutes to 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start15 Sep 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Kirsa Skov-Jeppesen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573934
- Sponsor's protocol ID
- UCHP-KS-2
- Acronym
- KS-2
- Status last verified
- Jan 2020
- First submitted
- 7 Jun 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of GLP-2 Mechanism of Action (KS-2)
- ClinicalTrials.gov ID
- NCT03573934
- Acronym / sponsor ID
- KS-2 / UCHP-KS-2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 29 Jun 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.
Effects of GLP-2 and GIP on bone remodeling in healthy young men.
Detailed description
We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLP-2 | Experimental | Other: GLP-2Glucagon-Like Peptide-2 (GLP-2) injection |
| GIP | Experimental | Other: GIPGlucose-dependent Insulinotropic polypeptide (GIP) injection |
| GLP-2+GIP | Experimental | Other: GLP-2+GIPGLP-2+GIP injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo injection |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.
Key exclusion criteria (1 listed)
- Chronic disease Smoking Medication Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<8,0 mmol/L Decreased renal function.
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-2GLP-2 | Other | GLP-2 |
| GIPGIP | Other | GIP |
| GLP-2+GIPGLP-2+GIP | Other | GLP-2+GIP |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Bone resorption
Time frame: From -10 minutes to 240 minutes.
C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.
Bone formation
Time frame: From -10 minutes to 240 minutes.
P1NP is a marker of bone formation. Measured in serum.
8 secondary outcomes
Parathyroid hormone
Time frame: From -10 minutes to 240 minutes.
Calcium
Time frame: From -10 minutes to 240 minutes.
GIP
Time frame: From -10 minutes to 240 minutes.
GLP-2
Time frame: From -10 minutes to 240 minutes.
Glucose
Time frame: From -10 minutes to 240 minutes.
Insulin
Time frame: From -10 minutes to 240 minutes.
C-peptide
Time frame: From -10 minutes to 240 minutes.
Sclerostin
Time frame: From -10 minutes to 240 minutes.
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 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-2, GIP and GLP-2+GIP in people with Healthy, run by University of Copenhagen 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 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 Jan 2020. 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. 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?
Bone resorption (time frame: From -10 minutes to 240 minutes.). 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 18 Jan 2020.