HealthyKS-3NCT03574064
Effects of Gut Peptides on Bone Remodeling
A study testing Glucagon-Like Peptide-2 (GLP-2), Glucose-dependent insulinotropic polypeptide (GIP) and GLP-2+GIP in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
We will investigate effects of gut hormones on bone remodeling. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glucagon-Like Peptide-2 (GLP-2), Glucose-dependent insulinotropic polypeptide (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
- 1 Jun 2018to 1 Jan 2019
- 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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women Age above 50 years Postmenopausal Caucasian BMI 18.5 to 28.0 kg/m2.
Who cannot join
- Smoking Medication believed to influence study outcome Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<7,0 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
We will investigate effects of gut hormones on bone remodeling.
- Conditions
- Healthy
- Being tested
- Glucagon-Like Peptide-2 (GLP-2), Glucose-dependent insulinotropic polypeptide (GIP), GLP-2+GIP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-Like Peptide-2 (GLP-2)Other
Glucagon-Like Peptide-2 (GLP-2) injection.
Glucose-dependent insulinotropic polypeptide (GIP)Other
Glucose-dependent insulinotropic polypeptide (GIP) injection.
GLP-2+GIPOther
GLP-2+GIP injection.
PlaceboOther
Placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| GLP-2 | Experimental | Glucagon-Like Peptide-2 (GLP-2) Receives: Other: Glucagon-Like Peptide-2 (GLP-2) |
| GIP | Experimental | Glucose-dependent Insulinotropic polypeptide (GIP) Receives: Other: Glucose-dependent insulinotropic polypeptide (GIP) |
| GLP-2+GIP | Experimental | GLP-2+GIP Receives: Other: GLP-2+GIP |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-terminal telopeptide (CTX). At all time points and AUC(0-240 min).
CTX is a marker of bone resorption. Measured in serum.
Measured: -10 minutes to 600 minutes
N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min).
P1NP is a marker of bone formation. Measured in serum.
Measured: -10 minutes to 600 minutes
Secondary outcomes (11)
PTH
Bone marker. Measured in serum.
Measured: -10 minutes to 600 minutes
Sclerostin
Bone marker.
Measured: -10 minutes to 600 minutes
Calcium
Measured in serum within 5 days.
Measured: -10 minutes to 600 minutes
Glucose
Measured in serum.
Measured: -10 minutes to 600 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Total and intact GIP. Measured in plasma.
Measured: -10 minutes to 600 minutes
Insulin
Measured in serum.
Measured: -10 minutes to 600 minutes
C-peptide
Measured in serum.
Measured: -10 minutes to 600 minutes
Glukagon-like peptide-1 (GLP-1)
Measured in plasma.
Measured: -10 minutes to 600 minutes
Glucagon
Measured in plasma.
Measured: -10 minutes to 600 minutes
Glukagon-like peptide-2 (GLP-2)
Intact GLP-2. Measured in plasma.
Measured: -10 minutes to 600 minutes
PP
Measured in plasma.
Measured: -10 minutes to 600 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 start1 Jun 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT03574064
- Sponsor's protocol ID
- UCPH-KS-3-18
- Acronym
- KS-3
- Status last verified
- Jan 2021
- First submitted
- 7 Jun 2018
- Last updated
- 20 Jan 2021
- Results posted
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of GLP-2 Mechanism of Action
- ClinicalTrials.gov ID
- NCT03574064
- Acronym / sponsor ID
- KS-3 / UCPH-KS-3-18
- 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
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (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.
We will investigate effects of gut hormones on bone remodeling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLP-2 | Experimental | Other: Glucagon-Like Peptide-2 (GLP-2)Glucagon-Like Peptide-2 (GLP-2) |
| GIP | Experimental | Other: Glucose-dependent insulinotropic polypeptide (GIP)Glucose-dependent Insulinotropic polypeptide (GIP) |
| GLP-2+GIP | Experimental | Other: GLP-2+GIPGLP-2+GIP |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women Age above 50 years Postmenopausal Caucasian BMI 18.5 to 28.0 kg/m2.
Key exclusion criteria (1 listed)
- Smoking Medication believed to influence study outcome Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<7,0 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 |
|---|---|---|
| Glucagon-Like Peptide-2 (GLP-2)Glucagon-Like Peptide-2 (GLP-2) injection. | Other | GLP-2 |
| Glucose-dependent insulinotropic polypeptide (GIP)Glucose-dependent insulinotropic polypeptide (GIP) injection. | Other | GIP |
| GLP-2+GIPGLP-2+GIP injection. | Other | GLP-2+GIP |
| PlaceboPlacebo injection. | Other | Placebo |
Primary outcome
C-terminal telopeptide (CTX). At all time points and AUC(0-240 min).
Time frame: -10 minutes to 600 minutes
CTX is a marker of bone resorption. Measured in serum.
N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min).
Time frame: -10 minutes to 600 minutes
P1NP is a marker of bone formation. Measured in serum.
11 secondary outcomes
PTH
Time frame: -10 minutes to 600 minutes
Sclerostin
Time frame: -10 minutes to 600 minutes
Calcium
Time frame: -10 minutes to 600 minutes
Glucose
Time frame: -10 minutes to 600 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Time frame: -10 minutes to 600 minutes
Insulin
Time frame: -10 minutes to 600 minutes
C-peptide
Time frame: -10 minutes to 600 minutes
Glukagon-like peptide-1 (GLP-1)
Time frame: -10 minutes to 600 minutes
Glucagon
Time frame: -10 minutes to 600 minutes
Glukagon-like peptide-2 (GLP-2)
Time frame: -10 minutes to 600 minutes
PP
Time frame: -10 minutes to 600 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 20 Jan 2021.
- 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 Glucagon-Like Peptide-2 (GLP-2), Glucose-dependent insulinotropic polypeptide (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 20 Jan 2021. 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?
C-terminal telopeptide (CTX). At all time points and AUC(0-240 min). (time frame: -10 minutes to 600 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 20 Jan 2021.