Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 3:47 AM
Study NCT ID:
NCT04232033
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol preference (How much do you want to drink alcohol?)', 'timeFrame': '1 year', 'description': 'Evaluated by Visual analogue scale from "not at all" to "more than ever"'}], 'secondaryOutcomes': [{'measure': 'Plasma glucose concentration', 'timeFrame': '1 year', 'description': 'Plasma glucose concentration'}, {'measure': 'Serum insulin concentration', 'timeFrame': '1 year', 'description': 'Serum insulin concentration'}, {'measure': 'Plasma fibroblast growth factor-21 concentration', 'timeFrame': '1 year', 'description': 'Plasma fibroblast growth factor-21 concentration'}, {'measure': 'Serum C-peptide concentration', 'timeFrame': '1 year', 'description': 'Serum C-peptide concentration'}, {'measure': 'Plasma glucagon concentration', 'timeFrame': '1 year', 'description': 'Serum C-peptide concentration'}, {'measure': 'Plasma lipid profile', 'timeFrame': '1 year', 'description': 'Plasma concentrations of triglycerides, total cholesterol, free fatty acids'}, {'measure': 'Plasma insulin-like growth factor 1 concentration', 'timeFrame': '1 year', 'description': 'Plasma insulin-like growth factor 1 concentration'}, {'measure': 'Plasma bone marker concentration', 'timeFrame': '1 year', 'description': 'Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide'}, {'measure': 'Resting energy expenditure', 'timeFrame': '1 year', 'description': 'Evaluated by indirect calorimetry'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibroblast Growth Factor 21', 'Tast Perference']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Caucasian male\n* Body mass index between 19 and 27 kg/m2\n* Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (\\< 42 mmol/mol)\n* Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)\n\nExclusion Criteria:\n\n* Liver diseases evaluated by plasma alanine aminotransferase (ALAT) \\> 3 × normal level or an International Normalized Ratio (INR) below normal values\n* Diabetes mellitus\n* Nephropathy\n* First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder\n* Other diseases the investigator finds disruptive for participation in the study'}, 'identificationModule': {'nctId': 'NCT04232033', 'acronym': 'AlcoPref', 'briefTitle': 'The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men', 'orgStudyIdInfo': {'id': 'H-19068397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fibroblast growth factor 21 infusion', 'description': 'Fibroblast growth factor 21 infusion', 'interventionNames': ['Other: Fibroblast growth factor 21 infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion (saline)', 'description': 'Saline infusion', 'interventionNames': ['Other: Placebo infusion (saline)']}], 'interventions': [{'name': 'Fibroblast growth factor 21 infusion', 'type': 'OTHER', 'description': 'Infusion of Fibroblast growth factor 21', 'armGroupLabels': ['Fibroblast growth factor 21 infusion']}, {'name': 'Placebo infusion (saline)', 'type': 'OTHER', 'description': 'Infusion of Saline', 'armGroupLabels': ['Placebo infusion (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Amalie R Lanng', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Amalie R Lanng, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Novo Nordisk Foundation Center for Basic Metabolic Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Filip Krag Knop', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}