Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT02336659
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2015-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083773', 'term': 'exendin (9-39)'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad libitum food intake (changes in food intake)', 'timeFrame': '3-12 month after RYGB', 'description': 'Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor'}], 'secondaryOutcomes': [{'measure': 'Glucose metabolism (iAUC of glucose and c-pep after a meal)', 'timeFrame': '3-12 month after RYGB', 'description': 'Evaluated by iAUC of glucose and c-pep after a meal'}, {'measure': 'Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)', 'timeFrame': '3-12 month after RYGB', 'description': 'Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal'}, {'measure': 'Appetite measurement (VAS-scores)', 'timeFrame': '3-12 month after RYGB', 'description': 'Evaluated by VAS-scores'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.', 'detailedDescription': 'To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose \\<7.0 mM and HbA1c \\< 48 mmol/mol 3 month after RYGB.\n\nExclusion Criteria:\n\n* Fasting plasma glucose \\>7.0 mM and HbA1c \\> 48 mmol/mol 3 month after RYGB. Hemoglobin \\<6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.\n* Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).'}, 'identificationModule': {'nctId': 'NCT02336659', 'briefTitle': 'Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'MSV-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Mixed meal test and ad libitum meal test duing infusion of saline', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Exendin 9-39', 'description': 'Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min', 'interventionNames': ['Drug: exendin 9-39']}, {'type': 'EXPERIMENTAL', 'label': 'DPP-4 Inhibition', 'description': 'Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg \\* 2', 'interventionNames': ['Drug: sitagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Exendin 9-39 / DPP 4-Inhibition', 'description': 'Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg \\* 2', 'interventionNames': ['Drug: exendin 9-39', 'Drug: sitagliptin']}], 'interventions': [{'name': 'exendin 9-39', 'type': 'DRUG', 'otherNames': ['GLP-1 antagonist'], 'description': 'Exendin 9-39 is a specific GLP-1 receptor antagonist', 'armGroupLabels': ['Exendin 9-39', 'Exendin 9-39 / DPP 4-Inhibition']}, {'name': 'sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'DPP-4 Inhibition', 'armGroupLabels': ['DPP-4 Inhibition', 'Exendin 9-39 / DPP 4-Inhibition']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Sten Madbad, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Maria Saur Svane', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}