Spinal Cord InjuriesNCT05181150
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
A study testing Meal test, GIP and GLP-2 in people with Spinal Cord Injuries, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Meal test, GIP and GLP-2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Nov 2021to Nov 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spinal cord injury resulting in the need of a wheelchair
- BMI: 16-32 kg/m2
- Intact spinal cord
- Matched on gender, age and BMI to the group with spinal cord injury
Who cannot join
- Treatment with antidiabetics
- Treatment with anti-resorptive agents
- Gastrointestinal disease
- Smoking
- Long term steroid treatment
- Weight change more than 3 kg within the last 3 months.
- Overweight or intestinal surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, 2650
Sten Madsbad, Sten.Madsbad@regionh.dk
Charlotte B Christiansen, cbchristiansen@sund.ku.dk
About this study
Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- Meal test, GIP, GLP-2, GIP + GLP-2, Placebo
- Keywords
- Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover, Bone remodeling
- Medical subject headings
- Spinal Cord Injuries, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal testOther
Also called Nutridrink
Ingestion of an oral liquid meal (nutridrink), 200 mL.
GIPOther
Subcutaneous GIP injection.
GLP-2Other
Subcutaneous GLP-2 injection.
GIP + GLP-2Other
Subcutaneous GIP + GLP-2 injection.
PlaceboOther
Subcutaneous saline injection.
| Study group | Role | What they receive |
|---|---|---|
| Meal test | Experimental | Not described Receives: Other: Meal test |
| GIP, Glucose-dependent insulinotropic polypeptide | Experimental | Not described Receives: Other: GIP |
| GLP-2, Glucagon-like-peptide-2 | Experimental | Not described Receives: Other: GLP-2 |
| GIP + GLP-2 | Experimental | Not described Receives: Other: GIP + GLP-2 |
| Placebo (saline) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTX
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
Measured: -10 to 240 minutes
Secondary outcomes (11)
P1NP
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
Measured: -10 to 240 minutes
PTH
PTH measured in serum PTH measured in serum
Measured: -10 to 240 minutes
Sclerostin
Bone marker
Measured: -10 to 240 minutes
Glucose
Measured in serum
Measured: -10 to 240 minutes
Insulin
Measured in serum
Measured: -10 to 240 minutes
C-peptide
Measured in serum
Measured: -10 to 240 minutes
GIP
Glucose-dependent insulinotropic polypeptide measured in plasma
Measured: -10 to 240 minutes
GLP-2
Glucagon-like peptide 2 measured in plasma.
Measured: -10 to 240 minutes
Glucagon
Glucagon measured in plasma
Measured: -10 to 240 minutes
Blood pressure
Measured before blood sampling
Measured: -10 to 240 minutes
Heart rate
Measured before blood sampling
Measured: -10 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 posted6 Jan 2022
- Study start16 Nov 2021
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- 20 participants (estimated)
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
- Investigators
- Mette M Rosenkilde, Prof., MD, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181150
- Sponsor's protocol ID
- CBC-SCI-21
- Status last verified
- May 2023
- First submitted
- 18 Dec 2021
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05181150
- Acronym / sponsor ID
- CBC-SCI-21
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 6 Jan 2022 (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.
Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Meal test | Experimental | Other: Meal test |
| GIP, Glucose-dependent insulinotropic polypeptide | Experimental | Other: GIP |
| GLP-2, Glucagon-like-peptide-2 | Experimental | Other: GLP-2 |
| GIP + GLP-2 | Experimental | Other: GIP + GLP-2 |
| Placebo (saline) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinal cord injury resulting in the need of a wheelchair
- BMI: 16-32 kg/m2
- Intact spinal cord
- Matched on gender, age and BMI to the group with spinal cord injury
Key exclusion criteria (7 listed)
- Treatment with antidiabetics
- Treatment with anti-resorptive agents
- Gastrointestinal disease
- Smoking
- Long term steroid treatment
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 |
|---|---|---|
| Meal testAlso: NutridrinkIngestion of an oral liquid meal (nutridrink), 200 mL. | Other | Meal test |
| GIPSubcutaneous GIP injection. | Other | GIP, Glucose-dependent insulinotropic polypeptide |
| GLP-2Subcutaneous GLP-2 injection. | Other | GLP-2, Glucagon-like-peptide-2 |
| GIP + GLP-2Subcutaneous GIP + GLP-2 injection. | Other | GIP + GLP-2 |
| PlaceboSubcutaneous saline injection. | Other | Placebo (saline) |
Primary outcome
CTX
Time frame: -10 to 240 minutes
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
11 secondary outcomes
P1NP
Time frame: -10 to 240 minutes
PTH
Time frame: -10 to 240 minutes
Sclerostin
Time frame: -10 to 240 minutes
Glucose
Time frame: -10 to 240 minutes
Insulin
Time frame: -10 to 240 minutes
C-peptide
Time frame: -10 to 240 minutes
GIP
Time frame: -10 to 240 minutes
GLP-2
Time frame: -10 to 240 minutes
Glucagon
Time frame: -10 to 240 minutes
Blood pressure
Time frame: -10 to 240 minutes
Heart rate
Time frame: -10 to 240 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Mette M Rosenkilde, Prof., MD study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal test, GIP and GLP-2 in people with Spinal Cord Injuries, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte B Christiansen, PhD (+45 22459802, cbchristiansen@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTX (time frame: -10 to 240 minutes). 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 May 2023.