Diabetes InsipidusGlucacopNCT04550520
Copeptin After a Subcutaneous Stimulation With Glucagon in Adults
A study testing Glucagon in people with Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia). It is to investigate whether glucagon stimulates the release of copeptin as a surrogate of vasopressin. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Insipidus
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Sep 2020to 30 May 2021
- 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
- Documented primary polydipsia or diabetes insipidus based on a water deprivation test or hypertonic saline Infusion
- Accordingly patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h, or must be on regular daily Desmopressin medication.
Who cannot join
- BMI > 25kg/m2 or < 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 19Show fewer
- Intention to become pregnant during the study
- Known allergy towards glucagon
- Evidence of an acute illness
- Long QT syndrome
- Hemoglobin level below 120 g/l
- BMI > 25kg/m2 or < 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 an acute illness
- Long QT syndrome
- Hemoglobin level below 120 g/l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Divison of Endocrinology, Diabetes and Metabolism,University Hospital Basel
Basel, 4031
About this study
Official title: Copeptin After a Subcutaneous Stimulation With Glucagon in Adults (Healthy Volunteers and Patients With Diabetes Insipidus or Primary Polydipsia) - The Glucacop-Study
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia). It is to investigate whether glucagon stimulates the release of copeptin as a surrogate of vasopressin.
Read the detailed description
The differentiation between central diabetes insipidus (cDI) and primary polydipsia (PP) is cumbersome. To date the test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline Infusion.
Instead of hypertonic saline Infusion, arginine infusion - known to stimulate growth hormone - is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%. Glucagon has been shown to stimulate GH-secretion. In analogy to the known stimulatory effect of arginine Infusion it is hypothesized that glucagon might stimulate the posterior pituitary gland and could therefore be a novel diagnostic test in the polyuria-polydipsia syndrome.
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia).
This study is planned as a double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. Participants will receive glucagon injection and placebo injection in random order.
- Conditions
- Diabetes Insipidus
- Being tested
- Glucagon, Placebo
- Keywords
- Copeptin, Glucagon, central diabetes insipidus, primary polydipsia, hypothalamo-pituitary-adrenal axis, posterior pituitary gland, polyuria-polydipsia syndrome
- Medical subject headings
- Diabetes Insipidus, Diabetes Insipidus, Neurogenic, Polydipsia, Psychogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDiagnostic test
Glucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483 g/mol, is a single-chain polypeptide containing 29 amino acid residues. Glucagon is provided in a single dose vial as powder. One container contains 1 mg of glucagon which results in a concentration of 1 mg/ml after dissolution in a volume of 1 ml (Glucagen NovoNordisk (Hypokit)). The currently used standard dose regimen is 1 mg of glucagon in adults. The solution for subcutaneous injection will be prepared by the study personnel according to the attached package leaflet.
PlaceboDiagnostic test
As placebo 1 ml sodium chloride (NaCl) 0.9% to inject subcutaneous is used. It has the same optical appearance as glucagon.
| Study group | Role | What they receive |
|---|---|---|
| study part 1: healthy adult volunteers | Experimental | 22 Healthy volunteers: The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). Receives: Diagnostic Test: Glucagon; Diagnostic Test: Placebo |
| study part 2: adult patients with primary polydipsia or central diabetes insipidus | Experimental | If results of study part 1 suggest that glucagon stimulates copeptin (proof of concept),10 patients with primary polydipsia and 10 patients with central diabetes insipidus will be additionally included (study part 2): The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). Receives: Diagnostic Test: Glucagon; Diagnostic Test: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal increase in copeptin level
Maximal increase in copeptin level within three hours after the injection of a single subcutaneous dose of 1mg glucagon or 0.9% NaCl. That is the difference between the maximal copeptin value measured between 30 and 180 minutes after the injection and the baseline value.
measured before the injection.
Measured: Within three hours after the injection
Secondary outcomes (11)
Change in copeptin values
Change in copeptin values
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Maximum copeptin time: the time from baseline to the maximum copeptin value
Maximum copeptin time: the time from baseline to the maximum copeptin value
Measured: Within three hours after the injection
Change in growth hormone (GH)
Change in growth hormone (GH)
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in prolactin
Change in prolactin
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in plasma sodium
Change in plasma sodium
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in plasma osmolality
Change in plasma osmolality
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in oxytocin
Change in oxytocin
Measured: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Maximal Change in GH
Maximal Change in GH
Measured: Within three hours after the injection
Maximal Change in prolactin
Maximal Change in prolactin
Measured: Within three hours after the injection
Maximal Change in plasma osmolality
Maximal Change in plasma osmolality
Measured: Within three hours after the injection
Maximal Change in oxytocin
Maximal Change in oxytocin
Measured: Within three hours after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start28 Sep 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes InsipidusStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). The randomization will be performed by an independent third party.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. med., Principal investigator, Endocrinology, Diabetes and Metabolism, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550520
- Sponsor's protocol ID
- 2020-02038; me20ChristCrain
- Acronym
- Glucacop
- Status last verified
- May 2022
- First submitted
- 9 Sep 2020
- Last updated
- 25 May 2022
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin After a Subcutaneous Stimulation With Glucagon in Adults (Healthy Volunteers and Patients With Diabetes Insipidus or Primary Polydipsia) - The Glucacop-Study
- ClinicalTrials.gov ID
- NCT04550520
- Acronym / sponsor ID
- Glucacop / 2020-02038; me20ChristCrain
- Conditions
- Diabetes Insipidus
- Keywords
- Copeptin, Glucagon, central diabetes insipidus, primary polydipsia, hypothalamo-pituitary-adrenal axis, posterior pituitary gland, polyuria-polydipsia syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 16 Sep 2020 (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 is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia). It is to investigate whether glucagon stimulates the release of copeptin as a surrogate of vasopressin.
Detailed description
The differentiation between central diabetes insipidus (cDI) and primary polydipsia (PP) is cumbersome. To date the test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline Infusion.
Instead of hypertonic saline Infusion, arginine infusion - known to stimulate growth hormone - is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%. Glucagon has been shown to stimulate GH-secretion. In analogy to the known stimulatory effect of arginine Infusion it is hypothesized that glucagon might stimulate the posterior pituitary gland and could therefore be a novel diagnostic test in the polyuria-polydipsia syndrome.
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia).
This study is planned as a double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. Participants will receive glucagon injection and placebo injection in random order.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). The randomization will be performed by an independent third party.
| Arm | Type | Receives |
|---|---|---|
| study part 1: healthy adult volunteers | Experimental | Diagnostic Test: Glucagon, Diagnostic Test: Placebo22 Healthy volunteers: The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). |
| study part 2: adult patients with primary polydipsia or central diabetes insipidus | Experimental | Diagnostic Test: Glucagon, Diagnostic Test: PlaceboIf results of study part 1 suggest that glucagon stimulates copeptin (proof of concept),10 patients with primary polydipsia and 10 patients with central diabetes insipidus will be additionally included (study part 2): The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- no medication except hormonal contraception
- Documented primary polydipsia or diabetes insipidus based on a water deprivation test or hypertonic saline Infusion
- Accordingly patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h, or must be on regular daily Desmopressin medication.
Key exclusion criteria (19 listed)
- BMI > 25kg/m2 or < 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 |
|---|---|---|
| GlucagonGlucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483 g/mol, is a single-chain polypeptide containing 29 amino acid residues. Glucagon is provided in a single dose vial as powder. One container contains 1 mg of glucagon which results in a concentration of 1 mg/ml after dissolution in a volume of 1 ml (Glucagen NovoNordisk (Hypokit)). The currently used standard dose regimen is 1 mg of glucagon in adults. The solution for subcutaneous injection will be prepared by the study personnel according to the attached package leaflet. | Diagnostic test | study part 1: healthy adult volunteers, study part 2: adult patients with primary polydipsia or central diabetes insipidus |
| PlaceboAs placebo 1 ml sodium chloride (NaCl) 0.9% to inject subcutaneous is used. It has the same optical appearance as glucagon. | Diagnostic test | study part 1: healthy adult volunteers, study part 2: adult patients with primary polydipsia or central diabetes insipidus |
Primary outcome
Maximal increase in copeptin level
Time frame: Within three hours after the injection
Maximal increase in copeptin level within three hours after the injection of a single subcutaneous dose of 1mg glucagon or 0.9% NaCl. That is the difference between the maximal copeptin value measured between 30 and 180 minutes after the injection and the baseline value. measured before the injection.
11 secondary outcomes
Change in copeptin values
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Maximum copeptin time: the time from baseline to the maximum copeptin value
Time frame: Within three hours after the injection
Change in growth hormone (GH)
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in prolactin
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in plasma sodium
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in plasma osmolality
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Change in oxytocin
Time frame: Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection
Maximal Change in GH
Time frame: Within three hours after the injection
Maximal Change in prolactin
Time frame: Within three hours after the injection
Maximal Change in plasma osmolality
Time frame: Within three hours after the injection
Maximal Change in oxytocin
Time frame: Within three hours after the injection
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 25 May 2022.
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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.
Mirjam Christ-Crain, Prof. Dr. med. 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 Glucagon in people with Diabetes Insipidus, 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 3 inclusion and 19 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 25 May 2022. 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?
Maximal increase in copeptin level (time frame: Within three hours after the injection). 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 25 May 2022.