Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-04 @ 11:31 PM
Study NCT ID:
NCT01374594
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GLP-1 secretion', 'timeFrame': 'Postprandial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '27270475', 'type': 'DERIVED', 'citation': 'Sonne DP, van Nierop FS, Kulik W, Soeters MR, Vilsboll T, Knop FK. Postprandial Plasma Concentrations of Individual Bile Acids and FGF-19 in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Aug;101(8):3002-9. doi: 10.1210/jc.2016-1607. Epub 2016 Jun 7.'}, {'pmid': '25908158', 'type': 'DERIVED', 'citation': 'Sonne DP, Vilsboll T, Knop FK. Pancreatic Amylase and Lipase Plasma Concentrations Are Unaffected by Increments in Endogenous GLP-1 Levels Following Liquid Meal Tests. Diabetes Care. 2015 May;38(5):e71-2. doi: 10.2337/dc14-2751. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'PURPOSE\n\nThe goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.\n\nIn the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects and type 2 diabetes patients (T2DM)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: (Healthy)\n\n* HbA1 \\< 6 %\n* Normal haemoglobin levels\n* Informed content\n\nInclusion Criteria: (T2DM)\n\n* T2DM \\> 5 years\n* Normal haemoglobin levels\n* Informed content\n\nExclusion Criteria: (T2DM)\n\n* Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues\n* Obesity (BMI \\> 30)\n* Age \\> 70 years\n* Gastrointestinal disease\n* Nephropathy\n* Liver disease\n* Medication which cannot be on hold for 12h\n* Gastrointestinal surgery\n\nExclusion Criteria: (Healthy)\n\n* 1st degree relatives with diabetes\n* Obesity (BMI \\> 30)\n* Age \\> 70 years\n* Gastrointestinal disease\n* Nephropathy\n* Liver disease\n* Medication which cannot be on hold for 12h\n* Gastrointestinal surgery'}, 'identificationModule': {'nctId': 'NCT01374594', 'briefTitle': 'Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'orgStudyIdInfo': {'id': 'GAL-INK II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults'}, {'label': 'Type 2 diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte University Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'David P. Sonne', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}