Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04550520
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2020-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Copeptin After a Subcutaneous Stimulation With Glucagon in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D020790', 'term': 'Diabetes Insipidus, Neurogenic'}, {'id': 'D059607', 'term': 'Polydipsia, Psychogenic'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D059606', 'term': 'Polydipsia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal increase in copeptin level', 'timeFrame': 'Within three hours after the injection', 'description': '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.\n\nmeasured before the injection.'}], 'secondaryOutcomes': [{'measure': 'Change in copeptin values', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in copeptin values'}, {'measure': 'Maximum copeptin time: the time from baseline to the maximum copeptin value', 'timeFrame': 'Within three hours after the injection', 'description': 'Maximum copeptin time: the time from baseline to the maximum copeptin value'}, {'measure': 'Change in growth hormone (GH)', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in growth hormone (GH)'}, {'measure': 'Change in prolactin', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in prolactin'}, {'measure': 'Change in plasma sodium', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in plasma sodium'}, {'measure': 'Change in plasma osmolality', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in plasma osmolality'}, {'measure': 'Change in oxytocin', 'timeFrame': 'Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection', 'description': 'Change in oxytocin'}, {'measure': 'Maximal Change in GH', 'timeFrame': 'Within three hours after the injection', 'description': 'Maximal Change in GH'}, {'measure': 'Maximal Change in prolactin', 'timeFrame': 'Within three hours after the injection', 'description': 'Maximal Change in prolactin'}, {'measure': 'Maximal Change in plasma osmolality', 'timeFrame': 'Within three hours after the injection', 'description': 'Maximal Change in plasma osmolality'}, {'measure': 'Maximal Change in oxytocin', 'timeFrame': 'Within three hours after the injection', 'description': 'Maximal Change in oxytocin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Copeptin', 'Glucagon', 'central diabetes insipidus', 'primary polydipsia', 'hypothalamo-pituitary-adrenal axis', 'posterior pituitary gland', 'polyuria-polydipsia syndrome'], 'conditions': ['Diabetes Insipidus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nInstead 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.\n\nThis study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for healthy volunteers:\n\n* no medication except hormonal contraception\n\nInclusion criteria for patients:\n\n* Documented primary polydipsia or diabetes insipidus based on a water deprivation test or hypertonic saline Infusion\n* 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.\n\nExclusion Criteria for healthy volunteers:\n\n* BMI \\> 25kg/m2 or \\< 18.5 kg/m2\n* participation in a trial with investigational drugs within 30 days\n* vigorous physical exercise within 24 hours before the study participation\n* Alcohol intake within 24 hours before study participation\n* pregnancy and breastfeeding\n* Evidence of disordered drinking habits and diuresis defined as polyuria \\>50ml/kg Body weight/24h and polydipsia \\>3l /24h\n* Intention to become pregnant during the study\n* Known allergy towards glucagon\n* Evidence of an acute illness\n* Long QT syndrome\n* Hemoglobin level below 120 g/l\n\nExclusion criteria for patients:\n\n* BMI \\> 25kg/m2 or \\< 18.5 kg/m2\n* participation in a trial with investigational drugs within 30 days\n* vigorous physical exercise within 24 hours before the study participation\n* Alcohol intake within 24 hours before study participation\n* pregnancy and breastfeeding\n* Evidence of an acute illness\n* Long QT syndrome\n* Hemoglobin level below 120 g/l'}, 'identificationModule': {'nctId': 'NCT04550520', 'acronym': 'Glucacop', 'briefTitle': 'Copeptin After a Subcutaneous Stimulation With Glucagon in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Copeptin After a Subcutaneous Stimulation With Glucagon in Adults (Healthy Volunteers and Patients With Diabetes Insipidus or Primary Polydipsia) - The Glucacop-Study', 'orgStudyIdInfo': {'id': '2020-02038; me20ChristCrain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study part 1: healthy adult volunteers', 'description': '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).', 'interventionNames': ['Diagnostic Test: Glucagon', 'Diagnostic Test: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'study part 2: adult patients with primary polydipsia or central diabetes insipidus', 'description': '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).', 'interventionNames': ['Diagnostic Test: Glucagon', 'Diagnostic Test: Placebo']}], 'interventions': [{'name': 'Glucagon', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['study part 1: healthy adult volunteers', 'study part 2: adult patients with primary polydipsia or central diabetes insipidus']}, {'name': 'Placebo', 'type': 'DIAGNOSTIC_TEST', 'description': 'As placebo 1 ml sodium chloride (NaCl) 0.9% to inject subcutaneous is used. It has the same optical appearance as glucagon.', 'armGroupLabels': ['study part 1: healthy adult volunteers', 'study part 2: adult patients with primary polydipsia or central diabetes insipidus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Divison of Endocrinology, Diabetes and Metabolism,University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology, Diabetes and Metabolism, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}