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Management of Glycemia Following a Pizza Meal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748251
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Federico II University
Information provided by (Responsible Party):
Angela Zanfardino, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: the patients ate a pizza that fermented for 8 hours Other: the patients ate a pizza that fermented for 24 hours Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Short fermented pizza
the patients ate a pizza that fermented for 8 hours
Other: the patients ate a pizza that fermented for 8 hours
Patients eat pizza prepared with controlled ingredients but fermented 8 hours

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




Primary Outcome Measures :
  1. Continuous glucose sensor data [ Time Frame: 11 hours ]
    mmol/L


Secondary Outcome Measures :
  1. Content of carbohydrates [ Time Frame: 1 hour ]
    µg/g


Other Outcome Measures:
  1. Content of amino acids [ Time Frame: 1 hour ]
    µg/g



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748251


Locations
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Italy
Centro di Diabetologia Pediatrica "G.Stoppoloni"
Naples, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Federico II University
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angela Zanfardino, Principal Investigator, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03748251    
Other Study ID Numbers: PZ_2018
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Zanfardino, University of Campania "Luigi Vanvitelli":
Continuous Subcutaneous Insulin Infusion
diet
postprandial glucose
postprandial hypoglycemia
postprandial hyperglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases