Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT01410292
Status:
UNKNOWN
Last Update Posted:
2011-08-05
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062407', 'term': 'Meals'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-04', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycemic control', 'timeFrame': 'fasting and post-prandial (differents times during 180 minutes)', 'description': 'glucose and insulin'}], 'secondaryOutcomes': [{'measure': 'measures of satiety and appetite', 'timeFrame': 'fasting and post-prandial (different times for 180 min)', 'description': 'ghrelin and subjective analogue scale of appetite'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fiber', 'glycemic index', 'glycemic response', 'diabetes', 'ghrelin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25833777', 'type': 'DERIVED', 'citation': 'Silva FM, Kramer CK, Crispim D, Azevedo MJ. A high-glycemic index, low-fiber breakfast affects the postprandial plasma glucose, insulin, and ghrelin responses of patients with type 2 diabetes in a randomized clinical trial. J Nutr. 2015 Apr;145(4):736-41. doi: 10.3945/jn.114.195339. Epub 2015 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.', 'detailedDescription': 'Design study:\n\nSingle-blind crossover randomized clinical trial\n\nHypothesis:\n\nA meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.\n\nTest meals:\n\nFour test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):\n\nTest Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)\n\nOutcomes:\n\nGlycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.\n\nLogistic:\n\nPatients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.\n\nAll participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes,\n* HbA1c \\< 9%,\n* BMI \\< 35kg/m²,\n* Metformin and/or diet as treatment for diabetes\n\nExclusion Criteria:\n\n* Use of insulin as diabetes treatment\n* digestive disease with malabsorption\n* diabetes neuropathy with gastroparesis'}, 'identificationModule': {'nctId': 'NCT01410292', 'briefTitle': 'Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'GPPG 10-0472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'meal D', 'description': 'low fiber and low GI', 'interventionNames': ['Other: GI and fiber meals', 'Other: meals']}, {'type': 'EXPERIMENTAL', 'label': 'meal C', 'description': 'low Fiber and High GI', 'interventionNames': ['Other: GI and fiber meals', 'Other: meals']}, {'type': 'EXPERIMENTAL', 'label': 'meal B', 'description': 'high Fiber and low GI', 'interventionNames': ['Other: GI and fiber meals', 'Other: meals']}, {'type': 'EXPERIMENTAL', 'label': 'meal A', 'description': 'high fiber and high GI meal', 'interventionNames': ['Other: GI and fiber meals', 'Other: meals']}], 'interventions': [{'name': 'GI and fiber meals', 'type': 'OTHER', 'description': 'meals with different fiber content and glycemic index', 'armGroupLabels': ['meal A', 'meal B', 'meal C', 'meal D']}, {'name': 'meals', 'type': 'OTHER', 'description': 'four different meal regarding GI and fiber content', 'armGroupLabels': ['meal A', 'meal B', 'meal C', 'meal D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Flávia M Silva', 'role': 'CONTACT', 'email': 'flavia.moraes.silva@hotmail.com', 'phone': '93771824'}, {'name': 'Thais Steemburgo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Kramer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giovana Menegotto', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Flávia M Silva', 'role': 'CONTACT', 'email': 'flavia.moraes.silva@hotmail.com', 'phone': '93771824'}], 'overallOfficials': [{'name': 'Flávia M Silva', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}, {'name': 'Thais Steemburgo', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}, {'name': 'Caroline Kramer', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}, {'name': 'Giovana Menegotto', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Mirela Jobim de Azevedo', 'oldOrganization': 'Endocrine Division of Hospital de Clínicas de Porto Alegre'}}}}