Management of Glycemia Following a Pizza Meal

NCT03748251 | Completed

• 1 other identifier: PZ_2018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Subcutaneous Insulin Infusion; diet; postprandial glucose; postprandial hypoglycemia; postprandial hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Continuous glucose sensor data

  mmol/L

  11 hours

Secondary Outcomes (1)

• Content of carbohydrates

  1 hour

Other Outcomes (1)

• Content of amino acids

  1 hour

Study Arms (2)

Short fermented pizza

EXPERIMENTAL

the patients ate a pizza that fermented for 8 hours

Other: the patients ate a pizza that fermented for 8 hours

Long fermented pizza

EXPERIMENTAL

the patients ate a pizza that fermented for 24 hours

Other: the patients ate a pizza that fermented for 24 hours

Interventions

the patients ate a pizza that fermented for 8 hours OTHER

Patients eat pizza prepared with controlled ingredients but fermented 8 hours

Short fermented pizza

the patients ate a pizza that fermented for 24 hours OTHER

Patients eat pizza prepared with controlled ingredients but fermented 24 hours

Long fermented pizza

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Federico II University: collaborator

Study Sites (1)

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, 80100, Italy

Location

Related Publications (8)

• 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: 24160252 RESULT

• 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: 15138460 RESULT

• 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: 8462382 RESULT

• 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: 26370244 RESULT

• 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: 22013887 RESULT

• 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: 21355715 RESULT

• 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: 15857224 RESULT

• 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.

  PMID: 31335171 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: February 14, 2018
• Primary Completion: March 21, 2018
• Study Completion: October 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)