HypoparathyroidismKS-4-HypoPTNCT03728959
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.
A study testing Liquid meal (Nutridrink), GIP and GLP-2 in people with Hypoparathyroidism, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Hypoparathyroidism (hypoPT) is characterized by low levels of PTH. In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Liquid meal (Nutridrink), GIP and GLP-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Sep 2018to 12 Apr 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 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 76
- Hypoparathyroidism
Who cannot join
- Diabetes
- Disease in the gastrointestinal tract
- Antiosteoporotic drug
- Long term steroid treatment (within the last 12 months)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).
Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.
In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.
- Conditions
- Hypoparathyroidism
- Being tested
- Liquid meal (Nutridrink), GIP, GLP-2, Placebo (saline)
- Keywords
- hypoparathyroidism, Glucose-dependent insulinotropic polypeptide (GIP), Glucagon-like peptide-2 (GLP-2), Bone remodeling, Bone resorption, Bone formation, C-terminal telopeptide (CTX), N-terminal propeptide of type 1 procollagen (P1NP)
- Medical subject headings
- Hypoparathyroidism, Bone Resorption, Xanthomatosis, Cerebrotendinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid meal (Nutridrink)Other
Liquid meal ingested over 1 minute.
GIPOther
Subcutaneous injected GIP
GLP-2Other
Subcutaneous injected GLP-2
Placebo (saline)Other
Subcutaneous injected Placebo (saline)
| Study group | Role | What they receive |
|---|---|---|
| Liquid meal (Nutridrink) | Experimental | Liquid meal (Nutridrink) Receives: Other: Liquid meal (Nutridrink) |
| GIP | Experimental | Glucose-dependent insulinotropic polypeptide Receives: Other: GIP |
| GLP-2 | Experimental | Glucagon-like peptide-2 Receives: Other: GLP-2 |
| Placebo (saline) | Experimental | Placebo (saline) Receives: Other: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of C-terminal telopeptide (CTX)
Marker of bone resorption, measured in serum
Measured: -10 to 240 minutes
N-terminal propeptide of type 1 procollagen (P1NP)
Marker of bone formation, concentration measured in serum
Measured: -10 to 240 minutes
Secondary outcomes (7)
PTH
PTH concentration measured in serum
Measured: -10 to 240 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Gut hormone, concentration measured in plasma
Measured: -10 to 240 minutes
Glucagon-like peptide-2 (GLP-2)
Gut hormone, concentration measured in plasma
Measured: -10 to 240 minutes
Glucagon-like peptide-1 (GLP-1)
Gut hormone, concentration measured in plasma
Measured: -10 to 240 minutes
Glucose
Glucose concentration measured in serum
Measured: -10 to 240 minutes
Insulin
Insulin concentration measured in serum
Measured: -10 to 240 minutes
C-peptide
C-peptide concentration measured in serum
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 posted2 Nov 2018
- Study start12 Sep 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies 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
- 7 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
- Investigators
- Mette Rosenkilde, MD, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728959
- Sponsor's protocol ID
- KS-4-HypoPT
- Acronym
- KS-4-HypoPT
- Status last verified
- Dec 2019
- First submitted
- 31 Oct 2018
- Last updated
- 12 Dec 2019
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).
- ClinicalTrials.gov ID
- NCT03728959
- Acronym / sponsor ID
- KS-4-HypoPT / KS-4-HypoPT
- Conditions
- Hypoparathyroidism
- Keywords
- hypoparathyroidism, Glucose-dependent insulinotropic polypeptide (GIP), Glucagon-like peptide-2 (GLP-2), Bone remodeling, Bone resorption, Bone formation, C-terminal telopeptide (CTX), N-terminal propeptide of type 1 procollagen (P1NP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 2 Nov 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.
Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.
In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liquid meal (Nutridrink) | Experimental | Other: Liquid meal (Nutridrink)Liquid meal (Nutridrink) |
| GIP | Experimental | Other: GIPGlucose-dependent insulinotropic polypeptide |
| GLP-2 | Experimental | Other: GLP-2Glucagon-like peptide-2 |
| Placebo (saline) | Experimental | Other: Placebo (saline)Placebo (saline) |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 76
- Hypoparathyroidism
Key exclusion criteria (5 listed)
- Diabetes
- Disease in the gastrointestinal tract
- Antiosteoporotic drug
- Long term steroid treatment (within the last 12 months)
- Pregnancy
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 |
|---|---|---|
| Liquid meal (Nutridrink)Liquid meal ingested over 1 minute. | Other | Liquid meal (Nutridrink) |
| GIPSubcutaneous injected GIP | Other | GIP |
| GLP-2Subcutaneous injected GLP-2 | Other | GLP-2 |
| Placebo (saline)Subcutaneous injected Placebo (saline) | Other | Placebo (saline) |
Primary outcome
Serum concentration of C-terminal telopeptide (CTX)
Time frame: -10 to 240 minutes
Marker of bone resorption, measured in serum
N-terminal propeptide of type 1 procollagen (P1NP)
Time frame: -10 to 240 minutes
Marker of bone formation, concentration measured in serum
7 secondary outcomes
PTH
Time frame: -10 to 240 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Time frame: -10 to 240 minutes
Glucagon-like peptide-2 (GLP-2)
Time frame: -10 to 240 minutes
Glucagon-like peptide-1 (GLP-1)
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
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 12 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoparathyroidism
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
RecruitingPhase 3
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
Hypoparathyroidism, Endocrine System Diseases
RecruitingPhase 3
Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism
Hypoparathyroidism, Chronic Hypoparathyroidism
RecruitingPhase 3
A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
Hypoparathyroidism
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
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 Rosenkilde, 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 Liquid meal (Nutridrink), GIP and GLP-2 in people with Hypoparathyroidism, 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 2 inclusion and 5 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 12 Dec 2019. 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.
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?
Serum concentration of C-terminal telopeptide (CTX) (time frame: -10 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 12 Dec 2019.