Bone Diseases, MetabolicAmyBoneNCT06186063
The Role of Amylin in Bone Metabolism
A study testing Pramlintide in people with Bone Diseases, Metabolic and Type 1 Diabetes, run by Filip Krag Knop at 1 site in Denmark.
Trial summary
The clinical study aims to investigate the effect of the intravenously administrated amylin analogue (pramlintide) on the circulating levels of C-terminal telopeptide of type I collagen (CTX-1) (a marker of bone resorption) and N-terminal propeptide of type I procollagen (P1NP) (a marker of bone formation) in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Metabolic, Type 1 Diabetes
- What is being tested?
- Pramlintide
- Type of treatment
- 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
- 12 Feb 2024to 1 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian ethnicity
- Age between 18 and 60 years
- BMI between 18.5 and 27 kg/m2
- Type 1 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%) and
- Type 1 diabetes duration of 2-20 years
- C-peptide negative (stimulated C-peptide ≤30 pmol/l)
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- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
- Normal vitamin D (>50 nmol/l)
- Informed consent
- Caucasian ethnicity
- Age between 18 and 60 years
- BMI between 18.5 and 27 kg/m2
- Fasting plasma glucose ≤7.0 mmol/l and glycated haemoglobin (HbA1c) <48 mmol/mol
- Normal blood haemoglobin (8.3-10.5 mmol/l (males) and 7.3 - 9.5 mmol/l (females))
- Normal plasma vitamin D (>50 nmol/l)
- Informed consent
Who cannot join
- Anaemia (haemoglobin below normal range)
- Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
- Nephropathy (eGFR <60 ml/min/1,73m2 and/or microalbuminuria)
- Microvascular complications except non-proliferative retinopathy
- Treatment with anti-osteoporosis medication or glucocorticoids
- Fractures within the last 6 months
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- For women: currently perimenopausal or postmenopausal
- Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)
- Pregnancy or breastfeeding
- Any physical or psychological condition that the investigator feels would interfere with trial participation
- Treatment with any glucose-lowering drugs beside insulin, treatment with medication against osteoporosis or treatment with any form of glucocorticoids
- Any form of diabetes (according to World Health Organization criteria)
- Anaemia (haemoglobin below normal range)
- Nephropathy (eGFR <60 ml/min/1,73m2 and/or microalbuminuria)
- Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) >2 × upper normal limit
- Any fractures within the last 6 months
- For women: currently perimenopausal or postmenopausal
- Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)
- Pregnancy or breastfeeding
- Any condition considered incompatible with participation by the investigators
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900
Filip K. Knop, Professor, MD, PhD, filip.krag.knop.01@regionh.dk
About this study
The clinical study aims to investigate the effect of the intravenously administrated amylin analogue (pramlintide) on the circulating levels of C-terminal telopeptide of type I collagen (CTX-1) (a marker of bone resorption) and N-terminal propeptide of type I procollagen (P1NP) (a marker of bone formation) in individuals with type 1 diabetes and matched healthy controls during fasting euglycemic conditions.
Read the detailed description
Using a randomised double blinded placebo-controlled crossover design the investigators will evaluate the effects of the intravenously administrated amylin analogue (pramlintide) on circulating levels of CTX-1 and P1NP in ten individuals with type 1 diabetes and ten healthy controls matched for age, gender and body mass index (BMI) during fasting and euglycemic conditions. Each participant will receive double-blinded infusions of pramlintide (3 pmol/kg/min) and saline on two separate study days performed in randomised order.
The primary endpoints are the relative changes in the plasma levels of P1NP and CTX-1. The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma CTX-1 and P1NP as well as %-changes from baseline including nadir.
The secondary endpoints encompass changes in plasma concentrations of calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, glucagon, insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 and glucagon-like peptide 2.
- Conditions
- Bone Diseases, Metabolic, Type 1 Diabetes
- Being tested
- Pramlintide, Placebo (saline) infusion
- Medical subject headings
- Bone Diseases, Metabolic, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramlintideOther
At time 0 min, continuous infusion of a stable amylin analogue (pramlintide) will be initiated at a rate of 3.0 pmol/kg/min. The infusion will be terminated after 180 minutes.
Placebo (saline) infusionOther
At time 0 min, continuous infusion of isotonic saline will be initiated at a rate of 150 ml/h. The infusion will be terminated after 180 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide infusion | Experimental | A stable amylin analogue. Receives: Other: Pramlintide |
| Placebo infusion | Placebo comparator | Isotonic saline (0.9% NaCl). Receives: Other: Placebo (saline) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma CTX-1 as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma P1NP as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Secondary outcomes (11)
Changes in plasma concentrations of glucagon.
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of insulin.
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of C-peptide.
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucose.
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP).
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucagon-like peptide 2 (GLP-2).
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of calcium.
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of parathyroid hormone (PTH)
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of alkaline phosphatase
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Changes in plasma concentrations of osteocalcin
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Measured: From -15 minutes to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start12 Feb 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Diseases, MetabolicStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators apply a randomized, double-blinded, placebo-controlled, crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filip Krag Knop
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K. Knop, Professor, MD, PhD, Principal investigator, Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186063
- Sponsor's protocol ID
- H-22050946
- Acronym
- AmyBone
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amylin in Bone Metabolism
- ClinicalTrials.gov ID
- NCT06186063
- Acronym / sponsor ID
- AmyBone / H-22050946
- Conditions
- Bone Diseases, Metabolic, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Filip Krag KnopUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Dec 2023 (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.
The clinical study aims to investigate the effect of the intravenously administrated amylin analogue (pramlintide) on the circulating levels of C-terminal telopeptide of type I collagen (CTX-1) (a marker of bone resorption) and N-terminal propeptide of type I procollagen (P1NP) (a marker of bone formation) in individuals with type 1 diabetes and matched healthy controls during fasting euglycemic conditions.
Detailed description
Using a randomised double blinded placebo-controlled crossover design the investigators will evaluate the effects of the intravenously administrated amylin analogue (pramlintide) on circulating levels of CTX-1 and P1NP in ten individuals with type 1 diabetes and ten healthy controls matched for age, gender and body mass index (BMI) during fasting and euglycemic conditions. Each participant will receive double-blinded infusions of pramlintide (3 pmol/kg/min) and saline on two separate study days performed in randomised order.
The primary endpoints are the relative changes in the plasma levels of P1NP and CTX-1. The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma CTX-1 and P1NP as well as %-changes from baseline including nadir.
The secondary endpoints encompass changes in plasma concentrations of calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, glucagon, insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 and glucagon-like peptide 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The investigators apply a randomized, double-blinded, placebo-controlled, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Pramlintide infusion | Experimental | Other: PramlintideA stable amylin analogue. |
| Placebo infusion | Placebo comparator | Other: Placebo (saline) infusionIsotonic saline (0.9% NaCl). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Caucasian ethnicity
- Age between 18 and 60 years
- BMI between 18.5 and 27 kg/m2
- Type 1 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%) and
- Type 1 diabetes duration of 2-20 years
Key exclusion criteria (20 listed)
- Anaemia (haemoglobin below normal range)
- Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
- Nephropathy (eGFR <60 ml/min/1,73m2 and/or microalbuminuria)
- Microvascular complications except non-proliferative retinopathy
- Treatment with anti-osteoporosis medication or glucocorticoids
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 |
|---|---|---|
| PramlintideAt time 0 min, continuous infusion of a stable amylin analogue (pramlintide) will be initiated at a rate of 3.0 pmol/kg/min. The infusion will be terminated after 180 minutes. | Other | Pramlintide infusion |
| Placebo (saline) infusionAt time 0 min, continuous infusion of isotonic saline will be initiated at a rate of 150 ml/h. The infusion will be terminated after 180 minutes. | Other | Placebo infusion |
Primary outcome
Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)
Time frame: From -15 minutes to 180 minutes
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma CTX-1 as well as %-changes from baseline including nadir.
Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)
Time frame: From -15 minutes to 180 minutes
The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma P1NP as well as %-changes from baseline including nadir.
11 secondary outcomes
Changes in plasma concentrations of glucagon.
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of insulin.
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of C-peptide.
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucose.
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP).
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of glucagon-like peptide 2 (GLP-2).
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of calcium.
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of parathyroid hormone (PTH)
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of alkaline phosphatase
Time frame: From -15 minutes to 180 minutes
Changes in plasma concentrations of osteocalcin
Time frame: From -15 minutes to 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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.
Filip K. Knop, Professor, MD, PhD principal investigator
Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pramlintide in people with Bone Diseases, Metabolic and Type 1 Diabetes, run by Filip Krag Knop 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 16 inclusion and 20 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 21 Feb 2024. 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 Mathilde K. Preskou, MD (+45 2349 6823, emma.mathilde.kirsmeier.preskou.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1) (time frame: From -15 minutes to 180 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 21 Feb 2024.