Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-28 @ 1:15 PM
Study NCT ID:
NCT01656057
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000069472', 'term': 'Colesevelam Hydrochloride'}, {'id': 'C079530', 'term': 'desulfated sincalide'}, {'id': 'D012844', 'term': 'Sincalide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D000499', 'term': 'Allylamine'}, {'id': 'D000498', 'term': 'Allyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002766', 'term': 'Cholecystokinin'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'c-peptide', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'glucagon', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Glucagon-Like Peptide-2', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Peptide YY', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Oxyntomodulin', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Glucose-Dependent Insulinotropic Peptide', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Bile acids', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Gastrin', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'CCK', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}, {'measure': 'Gall bladder emptying assessed ultrasonically', 'timeFrame': '-30, -15, 20, 40, 60, 90, 120, 150, 180'}, {'measure': 'Resting energy expenditure', 'timeFrame': '-10, 50, 210'}, {'measure': 'Estimation of satiety via visual analogue scale', 'timeFrame': '0, 30, 60, 90, 120, 150, 180, 240'}], 'primaryOutcomes': [{'measure': 'GLP-1 response as incremental area under curve (iAUC)', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}], 'secondaryOutcomes': [{'measure': 'Insulin', 'timeFrame': '-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bile acids', 'Gall bladder emptying', 'Human', 'Glucagon like peptide 1', 'GLP-1'], 'conditions': ['To Assess the Impact of Bile Acids on Human Glukagon-like-peptide-1 Secretion']}, 'referencesModule': {'references': [{'pmid': '27003305', 'type': 'DERIVED', 'citation': 'Rohde U, Sonne DP, Christensen M, Hansen M, Bronden A, Torang S, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Cholecystokinin-Induced Gallbladder Emptying and Metformin Elicit Additive Glucagon-Like Peptide-1 Responses. J Clin Endocrinol Metab. 2016 May;101(5):2076-83. doi: 10.1210/jc.2016-1133. Epub 2016 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The last couple of years it has been shown that bile acids not only acts as simple emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a central role in maintaining normal glucose tolerance and thus blood sugar. Given the above, bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific findings can be proven in human beings is uncertain.\n\nThe primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding orally Metformin or a sequestrant ("a bile acid binder") will further enhance this GLP-1 response.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c \\< 6,0%\n* Not anaemic\n* Written informed consent\n\nExclusion Criteria:\n\n* Liver disease\n* Nephropathy\n* fasting plasma glucose \\> 5,6mM\n* Diabetes running in the family (parents or grandparents)\n* Any medical treatment\n* A former medical history of liver- or bile disease\n* any surgical procedure conducted in the abdomen\n* Body mass index \\< 18,5 kg/m2 or \\> 25 kg/m2'}, 'identificationModule': {'nctId': 'NCT01656057', 'briefTitle': 'The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion', 'orgStudyIdInfo': {'id': 'GALINKUR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen+saline', 'description': 'Acetaminophen tablet 1500 mg via nasogastric tube + i.v. saline', 'interventionNames': ['Drug: Acetaminophen', 'Other: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Acetaminophen+CCK', 'description': 'Acetaminophen tablet 1500 mg via nasogastric tube + iv. CCK-8, 24 pmol/kg/hour', 'interventionNames': ['Drug: Acetaminophen', 'Other: Cholecystokinin-8']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin+saline', 'description': 'Metformin tablet 1500 mg + Acetaminophen tablet 1500 mg via nasogastric tube + i.v. saline', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Metformin', 'Other: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin+CCK', 'description': 'Metformin tablet 1500 mg + Acetaminophen tablet 1500 mg via nasogastric tube + iv. CCK-8, 24 pmol/kg/hour', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Metformin', 'Other: Cholecystokinin-8']}, {'type': 'EXPERIMENTAL', 'label': 'Colesevelam+saline', 'description': 'Colesevelam tablet 3750 mg + Acetaminophen tablet 1500 mg via nasogastric tube + iv. saline', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Colesevelam', 'Other: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Colesevelam+CCK', 'description': 'Colesevelam tablet 3750 mg + Acetaminophen tablet 1500 mg via nasogastric tube + iv. CCK-8, 24 pmol/kg/hour', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Colesevelam', 'Other: Cholecystokinin-8']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Paracetamol'], 'description': 'Acetaminophen dissolved in 50 ml of water', 'armGroupLabels': ['Acetaminophen+CCK', 'Acetaminophen+saline', 'Colesevelam+CCK', 'Colesevelam+saline', 'Metformin+CCK', 'Metformin+saline']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin + acetaminophen dissolved in 50 ml of water', 'armGroupLabels': ['Metformin+CCK', 'Metformin+saline']}, {'name': 'Colesevelam', 'type': 'DRUG', 'description': 'Colesevelam + acetaminophen dissolved in 50 ml of water', 'armGroupLabels': ['Colesevelam+CCK', 'Colesevelam+saline']}, {'name': 'Cholecystokinin-8', 'type': 'OTHER', 'otherNames': ['CCK-8'], 'description': 'iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes', 'armGroupLabels': ['Acetaminophen+CCK', 'Colesevelam+CCK', 'Metformin+CCK']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'iv. saline infusion 40 ml/hour for the first 60 minutes', 'armGroupLabels': ['Acetaminophen+saline', 'Colesevelam+saline', 'Metformin+saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen, Hellerup', 'country': 'Denmark', 'facility': 'University Hospital of Copenhagen, Gentofte Hospital, Diabetic Research Division'}], 'overallOfficials': [{'name': 'Ulrich Rohde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetic Research Division, Department of Internal Medicine, University Hospital of Copenhagen, Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Filip Krag Knop', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Filip Krag Knop', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}