Polyuria-polydipsia SyndromeMacicopNCT03844217
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
A study testing Macimorelin 0.5mg/kg body weight and Macimorelin 0.75mg/kg body weight in people with Polyuria-polydipsia Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyuria-polydipsia Syndrome
- What is being tested?
- Macimorelin 0.5mg/kg body weight and Macimorelin 0.75mg/kg body weight
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Mar 2019to 16 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No medication except hormonal contraception
Who cannot join
- Body Mass Index (BMI) > 40kg/m2 or BMI < 18.5 kg/m2
- participation in a trial with investigational drugs within 30 days
- vigorous physical exercise within 24 hours before the study participation
- Alcohol intake within 24 hours before study participation
- pregnancy and breastfeeding
- Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
Show all 9Show fewer
- a prolonged QT interval (QTc >500 ms) or concomitant treatment with drugs that prolong the QT/QTc.
- Intention to become pregnant during the course of the study
- Known allergy towards Macimorelin
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel Endocrinology, Diabetes and Metabolism
Basel, 4031
About this study
Official title: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
Read the detailed description
Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
- Conditions
- Polyuria-polydipsia Syndrome
- Being tested
- Macimorelin 0.5mg/kg body weight, Macimorelin 0.75mg/kg body weight
- Keywords
- Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macimorelin 0.5mg/kg body weightDrug
oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
Macimorelin 0.75mg/kg body weightDrug
oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
| Study group | Role | What they receive |
|---|---|---|
| Macimorelin 0.5mg/kg body weight | Experimental | Visit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin.
Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1.
Macimorelin 0.75mg/kg body weight Receives: Drug: Macimorelin 0.5mg/kg body weight; Drug: Macimorelin 0.75mg/kg body weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.5mg/kg body weight
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Secondary outcomes (10)
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight
evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.75mg/kg body weight
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Growth Hormone (GH) value (ng/mL)
evaluate GH values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)
evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in free thyroxine (fT4) value (ng/dL)
evaluate fT4 values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Thyreotropin (TSH) value (mU/L)
evaluate TSH values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Prolactin value (yg/L)
evaluate Prolactin values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Cortisol value (ng/mL)
evaluate Cortisol values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Adrenocorticotropin (ACTH) value ( pg/mL)
evaluate ACTH values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Luteotropin (LH) value (U/L)
evaluate LH values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Follicle-stimulating hormone value(FSH) (IU/mL)
evaluate FSH values after the intake of of a single oral-dose Macimorelin
Measured: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start7 Mar 2019
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyuria-polydipsia SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Diagnosis
- Intervention model
- Sequential
- Model description
- Prospective, proof-of concept diagnostic study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. MD, Principal investigator, Endocrinology, Diabetes and Metabolism, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844217
- Sponsor's protocol ID
- 2018-02205; me18ChristCrain4
- Other IDs
- 2018
- Acronym
- Macicop
- Status last verified
- Aug 2019
- First submitted
- 14 Feb 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Urwyler SA, Lustenberger S, Drummond JR, Soares BS, Vogt DR, Ammer N, Yuen KCJ, Ribeiro-Oliveira A, Christ-Crain M. Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. Pituitary. 2021 Aug;24(4):555-563. doi: 10.1007/s11102-021-01132-9. Epub 2021 Feb 22.
PubMed 33615399
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
- ClinicalTrials.gov ID
- NCT03844217
- Acronym / sponsor ID
- Macicop / 2018-02205; me18ChristCrain4
- Conditions
- Polyuria-polydipsia Syndrome
- Keywords
- Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 18 Feb 2019 (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.
This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
Detailed description
Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, proof-of concept diagnostic study
| Arm | Type | Receives |
|---|---|---|
| Macimorelin 0.5mg/kg body weight | Experimental | Drug: Macimorelin 0.5mg/kg body weight, Drug: Macimorelin 0.75mg/kg body weightVisit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin. Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1. Macimorelin 0.75mg/kg body weight |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No medication except hormonal contraception
Key exclusion criteria (9 listed)
- Body Mass Index (BMI) > 40kg/m2 or BMI < 18.5 kg/m2
- participation in a trial with investigational drugs within 30 days
- vigorous physical exercise within 24 hours before the study participation
- Alcohol intake within 24 hours before study participation
- pregnancy and breastfeeding
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 |
|---|---|---|
| Macimorelin 0.5mg/kg body weightoral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin | Drug | Macimorelin 0.5mg/kg body weight |
| Macimorelin 0.75mg/kg body weightoral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin | Drug | Macimorelin 0.5mg/kg body weight |
Primary outcome
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.5mg/kg body weight
10 secondary outcomes
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Growth Hormone (GH) value (ng/mL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in free thyroxine (fT4) value (ng/dL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Thyreotropin (TSH) value (mU/L)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Prolactin value (yg/L)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Cortisol value (ng/mL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Adrenocorticotropin (ACTH) value ( pg/mL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Luteotropin (LH) value (U/L)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in Follicle-stimulating hormone value(FSH) (IU/mL)
Time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
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 8 Aug 2019.
- Derived from this study: PubMed 33615399Urwyler SA, Lustenberger S, Drummond JR, Soares BS, Vogt DR, Ammer N, Yuen KCJ, Ribeiro-Oliveira A, Christ-Crain M. Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. Pituitary. 2021 Aug;24(4):555-563. doi: 10.1007/s11102-021-01132-9. Epub 2021 Feb 22.
Related trials for Polyuria-polydipsia Syndrome
Recruiting
Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
Arginine Vasopressin Deficiency, Primary Polydipsia
Not yet recruiting
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
Primary Polydipsia, Central Diabetes Insipidus
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.
Mirjam Christ-Crain, Prof. Dr. MD principal investigator
Endocrinology, Diabetes and Metabolism, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macimorelin 0.5mg/kg body weight and Macimorelin 0.75mg/kg body weight in people with Polyuria-polydipsia Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 9 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 8 Aug 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 Switzerland. 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?
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight (time frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844217, which also lists 1 linked publication.
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 8 Aug 2019.