Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-10 @ 3:11 PM
Study NCT ID:
NCT02374632
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2015-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test)', 'timeFrame': '0-240 min, 240-270 min, 0-75 min', 'description': 'Between groups differences in VAS scores after meal test and sham feeding test'}, {'measure': 'Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip)', 'timeFrame': '0 min', 'description': 'Between groups differences in gene variants investigated with a HumanCoreExome chip'}, {'measure': 'Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing)', 'timeFrame': 'feces sample at home before intervention', 'description': 'Between groups differences in gut microbiome investigated with next generation sequencing'}, {'measure': 'Food intake (Between groups differences in food intake evaluated by questionnaires and diet registration)', 'timeFrame': '4 weeks questionnaires and 4 days of registration', 'description': 'Between groups differences in food intake evaluated by questionnaires and diet registration'}, {'measure': 'Physical activity (Between groups differences in food intake evaluated by questionnaires and accelerometer)', 'timeFrame': '4 weeks questionnaires and14 days of registration', 'description': 'Between groups differences in food intake evaluated by questionnaires and accelerometer'}], 'primaryOutcomes': [{'measure': 'Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day)', 'timeFrame': '0-240 min', 'description': 'Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day'}, {'measure': 'Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)', 'timeFrame': '0-240 min', 'description': 'Between groups difference in iAUC PYY after fixed breakfast meal on saline day'}, {'measure': 'Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)', 'timeFrame': '0-240 min', 'description': 'Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day'}], 'secondaryOutcomes': [{'measure': 'Ad libitum food intake', 'timeFrame': '240 min', 'description': 'Between groups difference in ad lib food intake'}, {'measure': 'Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)', 'timeFrame': '240 min', 'description': 'Between groups difference in %change in ad lib food intake between saline and octreotide day'}, {'measure': 'Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)', 'timeFrame': '0-30 min', 'description': 'Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bariatric Surgery (Gastric Bypass)', 'Severe Obesity']}, 'descriptionModule': {'briefSummary': 'After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as \\<50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated primary Roux-en-Y gastric bypass \\>12 months ago\n* Postoperative weight loss of \\>60%EBL or \\<50%EBL.\n\nExclusion Criteria:\n\n* Inadequately treated thyroid disease\n* Hemoglobin \\<6.5 mM\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02374632', 'briefTitle': 'Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'orgStudyIdInfo': {'id': 'KBM-R2-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low EBL', 'description': 'Gastric bypass operated patients with low postoperative excess body weight loss (EBL) \\<50%.\n\nInterventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.', 'interventionNames': ['Other: Meal tests after saline injection', 'Other: Meal tests after octreotide injection', 'Other: Sham feeding']}, {'type': 'OTHER', 'label': 'High EBL', 'description': 'Gastric bypass operated patients with high postoperative excess body weight loss (EBL) \\>70% matched with respect to age, gender and preoperative BMI in the LowEBL group.\n\nInterventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.', 'interventionNames': ['Other: Meal tests after saline injection', 'Other: Meal tests after octreotide injection', 'Other: Sham feeding']}], 'interventions': [{'name': 'Meal tests after saline injection', 'type': 'OTHER', 'description': 'Fixed breakfast meal and ad libitum lunch meal', 'armGroupLabels': ['High EBL', 'Low EBL']}, {'name': 'Meal tests after octreotide injection', 'type': 'OTHER', 'description': 'Fixed breakfast meal and ad libitum lunch meal', 'armGroupLabels': ['High EBL', 'Low EBL']}, {'name': 'Sham feeding', 'type': 'OTHER', 'armGroupLabels': ['High EBL', 'Low EBL']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Department of Endocrinology, Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Kirstine Nyvold Bojsen-Moeller', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}