Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT03748251
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Glycemia Following a Pizza Meal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Content of amino acids', 'timeFrame': '1 hour', 'description': 'µg/g'}], 'primaryOutcomes': [{'measure': 'Continuous glucose sensor data', 'timeFrame': '11 hours', 'description': 'mmol/L'}], 'secondaryOutcomes': [{'measure': 'Content of carbohydrates', 'timeFrame': '1 hour', 'description': 'µg/g'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous Subcutaneous Insulin Infusion', 'diet', 'postprandial glucose', 'postprandial hypoglycemia', 'postprandial hyperglycemia'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '24160252', 'type': 'RESULT', 'citation': 'Combet E, Jarlot A, Aidoo KE, Lean ME. Development of a nutritionally balanced pizza as a functional meal designed to meet published dietary guidelines. Public Health Nutr. 2014 Nov;17(11):2577-86. doi: 10.1017/S1368980013002814. Epub 2013 Oct 28.'}, {'pmid': '15138460', 'type': 'RESULT', 'citation': 'Gallus S, Tavani A, La Vecchia C. Pizza and risk of acute myocardial infarction. Eur J Clin Nutr. 2004 Nov;58(11):1543-6. doi: 10.1038/sj.ejcn.1601997.'}, {'pmid': '8462382', 'type': 'RESULT', 'citation': 'Ahern JA, Gatcomb PM, Held NA, Petit WA Jr, Tamborlane WV. Exaggerated hyperglycemia after a pizza meal in well-controlled diabetes. Diabetes Care. 1993 Apr;16(4):578-80. doi: 10.2337/diacare.16.4.578.'}, {'pmid': '26370244', 'type': 'RESULT', 'citation': "Mauseth R, Lord SM, Hirsch IB, Kircher RC, Matheson DP, Greenbaum CJ. Stress Testing of an Artificial Pancreas System With Pizza and Exercise Leads to Improvements in the System's Fuzzy Logic Controller. J Diabetes Sci Technol. 2015 Sep 14;9(6):1253-9. doi: 10.1177/1932296815602098."}, {'pmid': '22013887', 'type': 'RESULT', 'citation': 'Pankowska E, Blazik M, Groele L. Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub 2011 Oct 20.'}, {'pmid': '21355715', 'type': 'RESULT', 'citation': 'De Palma A, Giani E, Iafusco D, Bosetti A, Macedoni M, Gazzarri A, Spiri D, Scaramuzza AE, Zuccotti GV. Lowering postprandial glycemia in children with type 1 diabetes after Italian pizza "margherita" (TyBoDi2 Study). Diabetes Technol Ther. 2011 Apr;13(4):483-7. doi: 10.1089/dia.2010.0163. Epub 2011 Feb 28.'}, {'pmid': '15857224', 'type': 'RESULT', 'citation': 'Jones SM, Quarry JL, Caldwell-McMillan M, Mauger DT, Gabbay RA. Optimal insulin pump dosing and postprandial glycemia following a pizza meal using the continuous glucose monitoring system. Diabetes Technol Ther. 2005 Apr;7(2):233-40. doi: 10.1089/dia.2005.7.233.'}, {'pmid': '31335171', 'type': 'DERIVED', 'citation': 'Zanfardino A, Confetto S, Curto S, Cocca A, Rollato AS, Zanfardino F, Troise AD, Testa V, Bologna O, Stanco M, Piscopo A, Cohen O, Miraglia Del Giudice E, Vitaglione P, Iafusco D. Demystifying the Pizza Bolus: The Effect of Dough Fermentation on Glycemic Response-A Sensor-Augmented Pump Intervention Trial in Children with Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2019 Dec;21(12):721-726. doi: 10.1089/dia.2019.0191. Epub 2019 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Glycemia following pizza consumption is typically managed with a dual wave insulin bolus. This study evaluated the effect of a simple bolus on glycemia following consumption of traditionally prepared pizzas with long (22 hours) or short (8 hours) dough fermentation periods.', 'detailedDescription': 'All participants received pizza prepared in one of two ways, as described below, on two separate days. On the first day, they were given a pizza prepared with dough fermented for 8 hours (pizza A), and on the second study day they received a pizza prepared with dough fermented for 24 hours (pizza B). Participants and their parents were blinded to the type of pizza served on each day. Both meals were served at 7.00 pm at the pizzeria where the pizza had been prepared, and consumed within 30 minutes.\n\nChildren and adolescents aged between 4 and 18 years with type 1 diabetes were eligible for inclusion in the study if they had received SIP therapy (MiniMed™ 640G, Medtronic, Tolochenaz, Switzerland) for at least 3 months One pizza of each type was prepared for chemical analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months\n\nExclusion Criteria:\n\n* Patients with HbA1c \\>8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness'}, 'identificationModule': {'nctId': 'NCT03748251', 'briefTitle': 'Management of Glycemia Following a Pizza Meal', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Demystifying the Pizza Bolus: the Effect of Dough Fermentation Time on Glycemic Response in Children With Type 1 Diabetes Mellitus Receiving Sensor-augmented Pump Therapy', 'orgStudyIdInfo': {'id': 'PZ_2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short fermented pizza', 'description': 'the patients ate a pizza that fermented for 8 hours', 'interventionNames': ['Other: the patients ate a pizza that fermented for 8 hours']}, {'type': 'EXPERIMENTAL', 'label': 'Long fermented pizza', 'description': 'the patients ate a pizza that fermented for 24 hours', 'interventionNames': ['Other: the patients ate a pizza that fermented for 24 hours']}], 'interventions': [{'name': 'the patients ate a pizza that fermented for 8 hours', 'type': 'OTHER', 'description': 'Patients eat pizza prepared with controlled ingredients but fermented 8 hours', 'armGroupLabels': ['Short fermented pizza']}, {'name': 'the patients ate a pizza that fermented for 24 hours', 'type': 'OTHER', 'description': 'Patients eat pizza prepared with controlled ingredients but fermented 24 hours', 'armGroupLabels': ['Long fermented pizza']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'Centro di Diabetologia Pediatrica "G.Stoppoloni"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federico II University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angela Zanfardino', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}