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Management of Glycemia Following a Pizza Meal

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
the patients ate a pizza that fermented for 8 hours
the patients ate a pizza that fermented for 24 hours
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months

Exclusion Criteria:

  • Patients with HbA1c >8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness

Sites / Locations

  • Centro di Diabetologia Pediatrica "G.Stoppoloni"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short fermented pizza

Long fermented pizza

Arm Description

the patients ate a pizza that fermented for 8 hours

the patients ate a pizza that fermented for 24 hours

Outcomes

Primary Outcome Measures

Continuous glucose sensor data
mmol/L

Secondary Outcome Measures

Content of carbohydrates
µg/g

Full Information

First Posted
November 16, 2018
Last Updated
November 19, 2018
Sponsor
University of Campania "Luigi Vanvitelli"
Collaborators
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT03748251
Brief Title
Management of Glycemia Following a Pizza Meal
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
Collaborators
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. Children 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short fermented pizza
Arm Type
Experimental
Arm Description
the patients ate a pizza that fermented for 8 hours
Arm Title
Long fermented pizza
Arm Type
Experimental
Arm Description
the patients ate a pizza that fermented for 24 hours
Intervention Type
Other
Intervention Name(s)
the patients ate a pizza that fermented for 8 hours
Intervention Description
Patients eat pizza prepared with controlled ingredients but fermented 8 hours
Intervention Type
Other
Intervention Name(s)
the patients ate a pizza that fermented for 24 hours
Intervention Description
Patients eat pizza prepared with controlled ingredients but fermented 24 hours
Primary Outcome Measure Information:
Title
Continuous glucose sensor data
Description
mmol/L
Time Frame
11 hours
Secondary Outcome Measure Information:
Title
Content of carbohydrates
Description
µg/g
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Content of amino acids
Description
µg/g
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months Exclusion Criteria: Patients with HbA1c >8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness
Facility Information:
Facility Name
Centro di Diabetologia Pediatrica "G.Stoppoloni"
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24160252
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.
Results Reference
result
PubMed Identifier
15138460
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.
Results Reference
result
PubMed Identifier
8462382
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.
Results Reference
result
PubMed Identifier
26370244
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.
Results Reference
result
PubMed Identifier
22013887
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.
Results Reference
result
PubMed Identifier
21355715
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.
Results Reference
result
PubMed Identifier
15857224
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.
Results Reference
result
PubMed Identifier
31335171
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.
Results Reference
derived

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Management of Glycemia Following a Pizza Meal

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