Management of Glycemia Following a Pizza Meal

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: the patients ate a pizza that fermented for 24 hours; Other: the patients ate a pizza that fermented for 8 hours

• Registration Number: NCT03748251
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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

Study Timeline

• Study Start: 2018-02-14
• Primary Completion: 2018-03-21
• Study Completion: 2018-10-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Long fermented pizza	the patients ate a pizza that fermented for 24 hours	the patients ate a pizza that fermented for 24 hours
Short fermented pizza	the patients ate a pizza that fermented for 8 hours	the patients ate a pizza that fermented for 8 hours

Primary Outcome Measures

Name	Time	Method
Continuous glucose sensor data	11 hours	mmol/L

Secondary Outcome Measures

Name	Time	Method
Content of carbohydrates	1 hour	µg/g

Trial Locations

Locations (1)

Centro di Diabetologia Pediatrica "G.Stoppoloni"; 🇮🇹 Naples, Italy