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OpenTrials
Completed

NCT Number: NCT03748251

Management of Glycemia Following a Pizza Meal

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, 80100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the patients ate a pizza that fermented for 8 hours

Other

Patients eat pizza prepared with controlled ingredients but fermented 8 hours

the patients ate a pizza that fermented for 24 hours

Other

Patients eat pizza prepared with controlled ingredients but fermented 24 hours

Primary outcomes

  1. Continuous glucose sensor data

    Time frame: 11 hours

    mmol/L

Secondary outcomes

  1. Content of carbohydrates

    Time frame: 1 hour

    µg/g

Other outcomes

  1. Content of amino acids

    Time frame: 1 hour

    µg/g

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Collaborators

  • Federico II University

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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