Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT01572402
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial oxidative stress', 'timeFrame': 'up to 2 months'}, {'measure': 'Postprandial plasma concentrations of gastrointestinal peptides', 'timeFrame': 'up to 2 months'}], 'secondaryOutcomes': [{'measure': 'Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides', 'timeFrame': 'up to 2 months'}, {'measure': 'Postprandial plasma lipids', 'timeFrame': 'up to 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Gastrointestinal peptides', 'Insulin secretion', 'Oxidative stress', 'Plasma lipids', 'Postprandial', 'Type 2 diabetes'], 'conditions': ['Type 2 Diabetes', 'Postprandial Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '25222490', 'type': 'DERIVED', 'citation': 'Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014.'}, {'pmid': '25141237', 'type': 'DERIVED', 'citation': 'Malinska H, Kahleova H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Belinova L, Hill M, Pelikanova T. Postprandial oxidative stress and gastrointestinal hormones: is there a link? PLoS One. 2014 Aug 20;9(8):e103565. doi: 10.1371/journal.pone.0103565. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': "Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180')."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 individuals with type 2 diabetes treated by diet only or oral hypogylycemic agents,\n* diabetes duration at least 1 year,\n* both men and women,\n* age 30-65 years,\n* BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent\n\nExclusion Criteria:\n\n* gravidity,\n* lactation,\n* drug abuse,\n* insulin therapy'}, 'identificationModule': {'nctId': 'NCT01572402', 'briefTitle': 'Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'orgStudyIdInfo': {'id': '5206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with type 2 diabetes', 'description': 'Study group: 40 individuals with type 2 diabetes treated by diet and/or oral hypogylycemic agents, diabetes duration at least 1 year, both men and women, age 30-65 years, BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent', 'interventionNames': ['Other: Bagueutte Cheese Gourmet (Crocodille)', 'Other: Cous-cous sandwich', "Other: McCountry sandwich (McDonald's)"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy subjects', 'description': 'Mean and women, age 30-70 years, no diabetes, no metabolic syndrome', 'interventionNames': ['Other: Bagueutte Cheese Gourmet (Crocodille)', 'Other: Cous-cous sandwich', "Other: McCountry sandwich (McDonald's)"]}], 'interventions': [{'name': 'Bagueutte Cheese Gourmet (Crocodille)', 'type': 'OTHER', 'description': '180g, energy 452.8 Kcal/1895.7 kJ, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.', 'armGroupLabels': ['Healthy subjects', 'Patients with type 2 diabetes']}, {'name': 'Cous-cous sandwich', 'type': 'OTHER', 'description': '235 g, energy 455,88 Kcal /1907,4 kJ, composition: carbohydrates 59,54 g (52,24%), proteins 12,47 g (10,57% %), lipids 18,85 g (37,31%), of which saturated 6,2 g, monounsaturated 11,49 g, polyunsaturated 28,26 g', 'armGroupLabels': ['Healthy subjects', 'Patients with type 2 diabetes']}, {'name': "McCountry sandwich (McDonald's)", 'type': 'OTHER', 'description': '150g, 455 kcal/1903,72 kJ, composition: carbohydrates 31 g (27,25%), proteins 24 g (21,1%), lipids 26 g (51,43%), of which saturated 10 g (38,45%)', 'armGroupLabels': ['Healthy subjects', 'Patients with type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Hana Kahleova', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hana Kahleova', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}