Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-11 @ 5:50 PM
Study NCT ID:
NCT03141632
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'C068637', 'term': 'calcium D-pantothenate, L-cysteine drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, placebo control, cross-over design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid intake', 'timeFrame': '8 hours', 'description': 'Fluid intake (ml) during an evaluation visit'}], 'secondaryOutcomes': [{'measure': 'Thirst', 'timeFrame': '8 hours', 'description': 'Thirst perception'}, {'measure': 'Urine volume', 'timeFrame': '24 hours', 'description': 'Urine volume in ml'}, {'measure': 'Urinary sodium', 'timeFrame': '24 hours', 'description': 'Urinary sodium excretion'}, {'measure': 'Electrolytes', 'timeFrame': '3 timpoints during 8 hours', 'description': 'Plasma electrolytes'}, {'measure': 'Urine electrolytes', 'timeFrame': '3 timpoints during 8 hours', 'description': 'Urine electrolytes'}, {'measure': 'copeptin', 'timeFrame': '3 timpoints during 8 hours', 'description': 'copeptin values'}, {'measure': 'renin', 'timeFrame': '3 timpoints during 8 hours', 'description': 'renin'}, {'measure': 'aldosterone', 'timeFrame': '3 timpoints during 8 hours', 'description': 'aldosterone'}, {'measure': 'Water and Salt', 'timeFrame': '3 timpoints during 8 hours', 'description': 'Brain Natriuretic Peptide (BNP)'}, {'measure': 'GLP-1', 'timeFrame': '3 timpoints during 8 hours', 'description': 'GLP-1'}, {'measure': 'Hypothalamus Pituitary Adrenal Axis (HPA)', 'timeFrame': '8 hours after Dexamethasone intake', 'description': 'cortisol value after Dexamethasone intake'}, {'measure': 'circadian rhythm', 'timeFrame': '16 hours', 'description': 'circadian rhythm of serum cortisol'}, {'measure': 'salivary cortisol', 'timeFrame': '16 hours', 'description': 'circadian rhythm of salivary cortisol'}, {'measure': 'ACTH', 'timeFrame': '16 hours', 'description': 'circadian rhythm of ACTH'}, {'measure': 'Hypothalamus Pituitary Adrenal Axis (HPA)', 'timeFrame': '0.5 hours', 'description': 'cortisol upon adrenocorticotropic hormone (ACTH) stimulation'}, {'measure': 'Hypothalamus Pituitary Adrenal Axis (HPA)', 'timeFrame': '24 hours', 'description': 'free urinary cortisol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thirst', 'Water-Electrolyte Imbalance']}, 'referencesModule': {'references': [{'pmid': '35134170', 'type': 'DERIVED', 'citation': 'Vukajlovic T, Sailer CO, Asmar A, Jensen BL, Vogt DR, Christ-Crain M, Winzeler B. Effect of a 3-Week Treatment with GLP-1 Receptor Agonists on Vasoactive Hormones in Euvolemic Participants. J Clin Endocrinol Metab. 2022 May 17;107(6):e2581-e2589. doi: 10.1210/clinem/dgac063.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in healthy volunteers compared to Placebo.', 'detailedDescription': 'GLP-1 analogues are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic properties of GLP-1 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Age 18 to 65 years\n\nExclusion Criteria:\n\n* Known or probable central or nephrogenic Diabetes insipidus, based on patient's history\n* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia\n* Primary Polydipsia, defined as more than 4 liters fluid intake per day\n* BMI \\<18 or \\>30kg/m2\n* Pregnancy\n* Previous treatment with GLP-1 agonists within the last 3 month\n* History of pancreatitis\n* Severe renal insufficiency (eGFR (CKD EPI) \\<30 ml/min/1,73 m2)\n* Cancer"}, 'identificationModule': {'nctId': 'NCT03141632', 'acronym': 'GATE', 'briefTitle': 'Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"', 'orgStudyIdInfo': {'id': 'GATE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide', 'description': 'Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['Verum'], 'description': 'Evaluation visit with assessment of fluid intake', 'armGroupLabels': ['Dulaglutide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Evaluation visit with assessment of fluid intake', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital fo Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}