Management of Glycemia Following a Pizza Meal

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748251
• Other study ID #: PZ_2018
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2018
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 1, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• the patients ate a pizza that fermented for 8 hours
Patients eat pizza prepared with controlled ingredients but fermented 8 hours
• the patients ate a pizza that fermented for 24 hours
Patients eat pizza prepared with controlled ingredients but fermented 24 hours

Locations

Country	Name	City	State
Italy	Centro di Diabetologia Pediatrica "G.Stoppoloni"	Naples

Sponsors (2)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"	Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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) — View 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. — View 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. — View 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. do — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Content of amino acids	µg/g	1 hour
Primary	Continuous glucose sensor data	mmol/L	11 hours
Secondary	Content of carbohydrates	µg/g	1 hour