Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT03892369
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2019-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FGF21 and Its Role in Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Three matched groups. Group A: participants diagnosed with alcohol dependence, group B: participants with a father diagnosed with alcohol dependence, and C: a healthy control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibroblast growthfactor-21', 'timeFrame': 'One year', 'description': 'Plasma FGF21 concentrations, a member of the endocrine FGF-family'}], 'secondaryOutcomes': [{'measure': 'Ethanol', 'timeFrame': 'One year', 'description': 'Plasma ethanol concentration'}, {'measure': 'Glucose', 'timeFrame': 'One year', 'description': 'Plasma glucose concentrations'}, {'measure': 'Insulin and C-peptide', 'timeFrame': 'One year', 'description': 'Serum insulin and C-peptide concentrations'}, {'measure': 'Glucagon', 'timeFrame': 'One year', 'description': 'Plasma glucagon concentration'}, {'measure': 'Tumor Necrosis Factor-alpha (TNF)', 'timeFrame': 'One year', 'description': 'Plasma TNF-alpha concentrations'}, {'measure': 'Lipopolysaccharide Binding Protein (LBP)', 'timeFrame': 'One year', 'description': 'Plasma LBP concentrations'}, {'measure': 'Interferon-gamma (INF)', 'timeFrame': 'One year', 'description': 'Plasma INF-gamma concentrations'}, {'measure': 'Interleukine-10 (IL-10)', 'timeFrame': 'One year', 'description': 'Plasma IL-10 concentrations'}, {'measure': 'Interleukine-8 (IL-8)', 'timeFrame': 'One year', 'description': 'Plasma IL-8 concentrations'}, {'measure': 'Interleukine-6 (IL-6)', 'timeFrame': 'One year', 'description': 'Plasma IL-6 concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol', 'FGF21', 'Alcohol dependence'], 'conditions': ['Alcohol Abuse or Dependence']}, 'descriptionModule': {'briefSummary': 'Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents with alcohol dependence, and C: 15 healthy matched controls without history of or disposition to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Caucasian males between 25 and 65 years of age\n* BMI between 19 and 27 kg/m2\n* Normal haemoglobin\n* Normal fasting plasma glucose concentration (\\< 6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (\\< 42 mmol/mol)\n\nParticipants with a father diagnosed with alcohol dependence (group B):\n\n* Father diagnosed with alcohol dependence\n* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)\n* Normal Alcohol Use Disorders Identification Test (AUDIT) score\n\nHealthy participants (group C):\n\n* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)\n* Normal AUDIT score\n\nExclusion Criteria:\n\n* Liver disease evaluated by plasma alanine aminotransferase (ALAT) \\> 3 × normal level, an international normalised ratio (INR) below normal values, or biopsy-verified alcoholic liver disease\n* Diabetes mellitus\n* Anaemia\n* Nephropathy\n* Other diseases the investigator finds disruptive for participation in the study.\n\nParticipants with a father diagnosed with alcohol dependence (group B):\n\n\\- Former alcohol dependence or abuse\n\nHealthy participants (group C):\n\n* First-degree relatives with diabetes, liver disease and/or alcohol dependence\n* Former alcohol dependence'}, 'identificationModule': {'nctId': 'NCT03892369', 'acronym': 'AlcoDep', 'briefTitle': 'FGF21 and Its Role in Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence', 'orgStudyIdInfo': {'id': 'H-18063495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol', 'description': 'The participant receive 0.5 g ethanol per kg body weight over 10 minutes. Subsequently blood samples are taken frequently the next ten hours.', 'interventionNames': ['Other: Ethanol']}], 'interventions': [{'name': 'Ethanol', 'type': 'OTHER', 'description': 'Ethanol administration', 'armGroupLabels': ['Alcohol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Clinical Metabolic Research, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Filip K Knop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD', 'investigatorFullName': 'Filip Krag Knop', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}