Management of Glycemia Following a Pizza Meal

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: the patients ate a pizza that fermented for 24 hours; Other: the patients ate a pizza that fermented for 8 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT03748251

PZ_2018

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Short fermented pizza

Experimental group

Description:

the patients ate a pizza that fermented for 8 hours

Treatment:

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

Long fermented pizza

Experimental group

Description:

the patients ate a pizza that fermented for 24 hours

Treatment:

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