Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT03426956
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose Absorption and Gut Hormone Secretion After Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '10 gastric bypass patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in GLP-1 secretion (evaluated by iAUC).', 'timeFrame': '0-240 min following glucose ingestion', 'description': 'Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days.'}], 'secondaryOutcomes': [{'measure': 'Difference in glucose responses between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in insulin responses between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in C-peptide responses between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following carbohydrate ingestion'}, {'measure': 'Difference in glucagon responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following carbohydrate ingestion'}, {'measure': 'Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}, {'measure': 'Difference in bile acid responses (evaluated by iAUC) between the two test days.', 'timeFrame': '0-240 min following glucose ingestion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucagon-like Peptide-1', 'Glucose', 'Gastric bypass', 'Bariatric surgery', 'Obesity', 'Diabetes'], 'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.', 'detailedDescription': 'Glucose is a potent stimulus for GLP-1 secretion after gastric bypass surgery and the SGLT-1 transporter appears to be crucial for this response. The study will investigate the effects of SGLT-1/SGLT-2 inhibition (by canagliflozin) on secretion of GLP-1 and other gut hormones after gastric bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Uncomplicated gastric bypass surgery performed minimum 12 months prior to study\n\nExclusion Criteria:\n\n* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery\n* Pregnancy or breastfeeding\n* Haemoglobin levels below 6,5 mM'}, 'identificationModule': {'nctId': 'NCT03426956', 'briefTitle': 'Glucose Absorption and Gut Hormone Secretion After Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass', 'orgStudyIdInfo': {'id': 'CM-CANA-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose', 'interventionNames': ['Dietary Supplement: Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Glucose + Canagliflozin', 'interventionNames': ['Dietary Supplement: Glucose + Canagliflozin']}], 'interventions': [{'name': 'Glucose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of glucose (50 g) dissolved in 200 ml water.', 'armGroupLabels': ['Glucose']}, {'name': 'Glucose + Canagliflozin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.', 'armGroupLabels': ['Glucose + Canagliflozin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christoffer Martinussen, MD', 'role': 'CONTACT', 'email': 'christoffer.martinussen@regionh.dk', 'phone': '+4538623032'}, {'name': 'Christoffer Martinussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Endocrinology', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Sten Madsbad, Professor', 'role': 'CONTACT', 'email': 'sten.madsbad@regionh.dk', 'phone': '+4538623032'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Medical Doctor', 'investigatorFullName': 'Christoffer Martinussen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}