Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 3:35 PM
Study NCT ID:
NCT04018105
Status:
UNKNOWN
Last Update Posted:
2022-08-19
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Preprandial Metformin Administration on Carbohydrate Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of D-Xylose', 'timeFrame': 'During the 3 hours OGTT'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with gastrointestinal side effects', 'timeFrame': 'During the 3 hours OGTT'}, {'measure': 'Area under the curve of blood glucose', 'timeFrame': 'During the 3 hours OGTT'}, {'measure': 'Area under the curve of insulin', 'timeFrame': 'During the 3 hours OGTT'}, {'measure': 'Area under the curve of GLP-1', 'timeFrame': 'During the 3 hours OGTT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impaired glucose tolerance', 'type 2 diabetes', 'obesity', 'carbohydrate absorption', 'metformin'], 'conditions': ['Impaired Glucose Tolerance', 'Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption.\n\nIt is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake.\n\nTo study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity (BMI ≥30 kg/m2)\n* Dysglycemia (HbA1c≥ 6,0 %)\n* No anti diabetic medication\n\nExclusion Criteria:\n\n* No obesity (BMI \\< 30 kg/m2)\n* No dysglycemia (HbA1c \\<6,0%)\n* Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)\n* Anemia (Hb \\<12 g/dL)\n* Organ failure\n* Inflammatory Bowel Disease'}, 'identificationModule': {'nctId': 'NCT04018105', 'acronym': 'METTIME', 'briefTitle': 'Influence of Preprandial Metformin Administration on Carbohydrate Absorption', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Influence of Preprandial Metformin Administration on Carbohydrate Absorption: Pilot Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2018_35'}, 'secondaryIdInfos': [{'id': '2019-001175-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'taking metformin 30 or 60 minutes before the OGTT', 'interventionNames': ['Other: Oral glucose tolerance test (OGTT) with or without metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No metformin before OGTT', 'interventionNames': ['Other: Oral glucose tolerance test (OGTT) with or without metformin']}], 'interventions': [{'name': 'Oral glucose tolerance test (OGTT) with or without metformin', 'type': 'OTHER', 'description': 'Each participant will have 3 OGTT, one without metformin, one with metformin30 minutes before the test, one with metformin 60 minutes before the test. The order for each test will be randomized.', 'armGroupLabels': ['No metformin before OGTT', 'taking metformin 30 or 60 minutes before the OGTT']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Camille Marciniak, MD', 'role': 'CONTACT', 'email': 'camille.marciniak@chru-lille.fr', 'phone': '03.20.44.67.37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'camille Marciniak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}