Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-29 @ 6:28 AM
Study NCT ID:
NCT01840020
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bioavailability of ethanol', 'timeFrame': 'from baseline to 3 months, 1 year, and 3 years', 'description': 'bioavailability tests: Plasma concentration of ethanol. Calculation:\n\n* Area under curve (AUC)\n* Maximum concentration(Cmax)\n* Time up to maximum concentration (tmax)\n* Oral bioavailability (AUCpo/AUCiv)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'alcohol drinking', 'alcoholism', 'ethanol', 'metabolism'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.\n\nIn this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteers from Central Norway\n* morbid obese BMI \\> 40 kg/m2)\n* morbid obese BMI \\> 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery\n\nExclusion Criteria:\n\n* previous or current alcohol abuse\n* risk for alcohol harm as assessed by AUDIT\n* alcohol abstinence\n* liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery\n* previous colon resection\n* not/insufficiently able to informed consent\n* drugs that interact with alcohol dehydrogenase\n* drugs that slow down emptying of the stomach\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01840020', 'briefTitle': 'BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Changes in Bioavailability of Ethanol Following Bariatric Surgery', 'orgStudyIdInfo': {'id': '2012/1206'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric bypass', 'description': 'patients recruited from Central Norway', 'interventionNames': ['Procedure: Gastric bypass']}, {'label': 'Gastric sleeve', 'description': 'patients recruited from Central Norway', 'interventionNames': ['Procedure: gastric sleeve']}], 'interventions': [{'name': 'Gastric bypass', 'type': 'PROCEDURE', 'description': 'Surgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis.', 'armGroupLabels': ['Gastric bypass']}, {'name': 'gastric sleeve', 'type': 'PROCEDURE', 'description': 'Sleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape.', 'armGroupLabels': ['Gastric sleeve']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Namsos', 'country': 'Norway', 'facility': 'Sykehuset Namsos', 'geoPoint': {'lat': 64.46624, 'lon': 11.49572}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Obesity policlinic of St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Magnus Strommen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}