Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:36 PM
Study NCT ID:
NCT00767208
Status:
COMPLETED
Last Update Posted:
2009-05-20
First Post:
2008-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes and Metabolic Postprandial Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-19', 'studyFirstSubmitDate': '2008-10-06', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism', 'timeFrame': '6 hours postprandially'}], 'secondaryOutcomes': [{'measure': 'Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides', 'timeFrame': '6 hours postprandially'}, {'measure': 'Carbohydrate and lipid oxidation', 'timeFrame': '6 hours postprandially'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetic subjects'], 'conditions': ['Type 2 Diabetes', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese volunteers\n* Healthy for one group nd type 2 diabetic for the second group\n* Age between 30 and 65 years old\n* Total cholesterol \\< or = 7 mmol/l and triglycerides \\< or = 4 mmol/l\n* For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c \\< 6%\n* Stable weight over last 3 months\n* Informed consent\n\nExclusion Criteria:\n\n* No compliant subjects\n* Participation in an other trial 2 months before starting this one\n* Ward of court or under guardianship (sheltered adults)\n* Person deprived of freedom by judicial or administrative decision\n* Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose\n* Existence of a previously diagnosed pathology (other than type 2 diabetes)\n* Previous gastro-intestinal pathology\n* Treated by corticoids, anorexigens, weight loss medicines\n* Alcoholism or severe tobacco consumption'}, 'identificationModule': {'nctId': 'NCT00767208', 'briefTitle': 'Diabetes and Metabolic Postprandial Responses', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe'}, 'officialTitle': 'Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects', 'orgStudyIdInfo': {'id': 'CRNHRA-06-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'type 2 diabetic subjects', 'interventionNames': ['Other: oral glucose load']}, {'type': 'EXPERIMENTAL', 'label': 'overweight healthy subjects', 'interventionNames': ['Other: oral glucose load']}], 'interventions': [{'name': 'oral glucose load', 'type': 'OTHER', 'description': 'oral ingestion of 13C labeled glucose', 'armGroupLabels': ['overweight healthy subjects', 'type 2 diabetic subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre de Recherche En Nutrition Humaine Rhone Alpes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe', 'class': 'OTHER'}, 'collaborators': [{'name': 'LESAFFRE SA', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Pr Martine Laville', 'oldOrganization': 'CENTRE DE RECHERCHE EN NUTRITION HUMAINE RHONE ALPES'}}}}