Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-03 @ 10:11 PM
Study NCT ID:
NCT01559792
Status:
UNKNOWN
Last Update Posted:
2012-03-21
First Post:
2012-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Band to Bypass - Metabolism Kinetics in Gastric Bypass and Banding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Bypass', 'Gastric Banding']}, 'referencesModule': {'references': [{'pmid': '26245808', 'type': 'DERIVED', 'citation': 'Bojsen-Moller KN, Jacobsen SH, Dirksen C, Jorgensen NB, Reitelseder S, Jensen JE, Kristiansen VB, Holst JJ, van Hall G, Madsbad S. Accelerated protein digestion and amino acid absorption after Roux-en-Y gastric bypass. Am J Clin Nutr. 2015 Sep;102(3):600-7. doi: 10.3945/ajcn.115.109298. Epub 2015 Aug 5.'}, {'pmid': '23893303', 'type': 'DERIVED', 'citation': 'Jacobsen SH, Bojsen-Moller KN, Dirksen C, Jorgensen NB, Clausen TR, Wulff BS, Kristiansen VB, Worm D, Hansen DL, Holst JJ, van Hall G, Madsbad S. Effects of gastric bypass surgery on glucose absorption and metabolism during a mixed meal in glucose-tolerant individuals. Diabetologia. 2013 Oct;56(10):2250-4. doi: 10.1007/s00125-013-3003-0. Epub 2013 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to study the changes in secretion of gastrointestinal hormones, absorption and metabolism of food and liquids before and after gastric bypass and in patients who are gastric banded but are getting conversion to a gastric bypass. All patients are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is faster after gastric bypass and the secretion of gastrointestinal hormones change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all with normal glucose tolerance - patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal glucose tolerance\n* Patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass\n\nExclusion Criteria:\n\n* Diabetes,\n* Study population must undergo gastric bypass'}, 'identificationModule': {'nctId': 'NCT01559792', 'briefTitle': 'Band to Bypass - Metabolism Kinetics in Gastric Bypass and Banding', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Gastric Banding to Bypass - Metabolism Kinetics in Gastric Bypass and Banding', 'orgStudyIdInfo': {'id': 'BG092011'}}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Siv H Jacobsen', 'role': 'CONTACT'}, {'name': 'Siv H Jacobsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'siv H Jacobsen, MD', 'role': 'CONTACT'}], 'facility': 'Hvidovre hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'siv H Jacobsne, MD', 'role': 'CONTACT', 'email': 'siv.hesse@hotmail.com', 'phone': '+4538626357'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Siv Hesse Jacobsen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}