Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-24 @ 9:50 PM
Study NCT ID:
NCT02161666
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and serum specimens are retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in islet cell function from baseline (preoperatively)', 'timeFrame': '>24 months', 'description': 'Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass'}], 'secondaryOutcomes': [{'measure': 'Change in glucose tolerance during oral glucose tolerance test', 'timeFrame': '>24 months', 'description': 'Fasting, peak and nadir glucose during oral glucose tolerance test'}, {'measure': 'Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass', 'timeFrame': '>24 months', 'description': 'Differences in arterial and venous plasma glucose during oral glucose stimulation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Gastric Bypass', 'Bariatric Surgery', 'Incretin Function', 'Islet Function'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27138601', 'type': 'DERIVED', 'citation': 'Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.'}]}, 'descriptionModule': {'briefSummary': 'To examine pancreatic islet function and incretin function during intravenous and oral stimulation \\>2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in previous study (NCT01559779)\n\nExclusion Criteria:\n\n* Pregnancy/lactation\n* Major chronic disease develop since previous examination with possible impact on outcomes'}, 'identificationModule': {'nctId': 'NCT02161666', 'briefTitle': 'Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'orgStudyIdInfo': {'id': 'AB-CD-10-2Y'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery'}, {'label': 'Controls', 'description': 'Age, sex and BMI-matched healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Danmark', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Carsten Dirksen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Carsten Dirksen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}