Diabetes Mellitus, Type 1NCT03748251
Management of Glycemia Following a Pizza Meal
A study testing the patients ate a pizza that fermented for 8 hours and the patients ate a pizza that fermented for 24 hours in people with Diabetes Mellitus, Type 1, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- the patients ate a pizza that fermented for 8 hours and the patients ate a pizza that fermented for 24 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months
Who cannot join
- Patients with HbA1c >8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- the patients ate a pizza that fermented for 8 hours, the patients ate a pizza that fermented for 24 hours
- Keywords
- Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the patients ate a pizza that fermented for 8 hoursOther
Patients eat pizza prepared with controlled ingredients but fermented 8 hours
the patients ate a pizza that fermented for 24 hoursOther
Patients eat pizza prepared with controlled ingredients but fermented 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Short fermented pizza | Experimental | the patients ate a pizza that fermented for 8 hours Receives: Other: the patients ate a pizza that fermented for 8 hours |
| Long fermented pizza | Experimental | the patients ate a pizza that fermented for 24 hours Receives: Other: the patients ate a pizza that fermented for 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose sensor data
mmol/L
Measured: 11 hours
Secondary outcomes (1)
Content of carbohydrates
µg/g
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start14 Feb 2018
- Primary completion21 Mar 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Principal investigator, Angela Zanfardino, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748251
- Sponsor's protocol ID
- PZ_2018
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24160252Gallus S, Tavani A, La Vecchia C. Pizza and risk of acute myocardial infarction. Eur J Clin Nutr. 2004 Nov;58(11):1543-6. doi: 10.1038/sj.ejcn.1601997.
PubMed 15138460Ahern 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. doi: 10.2337/diacare.16.4.578.
PubMed 8462382Mauseth 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. doi: 10.1177/1932296815602098.
PubMed 26370244Pankowska 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 2011 Oct 20.
PubMed 22013887De 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):483-7. doi: 10.1089/dia.2010.0163. Epub 2011 Feb 28.
PubMed 21355715Jones 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. doi: 10.1089/dia.2005.7.233.
PubMed 15857224Zanfardino A, Confetto S, Curto S, Cocca A, Rollato AS, Zanfardino F, Troise AD, Testa V, Bologna O, Stanco M, Piscopo A, Cohen O, Miraglia Del Giudice E, Vitaglione P, Iafusco D. Demystifying the Pizza Bolus: The Effect of Dough Fermentation on Glycemic Response-A Sensor-Augmented Pump Intervention Trial in Children with Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2019 Dec;21(12):721-726. doi: 10.1089/dia.2019.0191. Epub 2019 Aug 8.
PubMed 31335171
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03748251
- Acronym / sponsor ID
- PZ_2018
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short fermented pizza | Experimental | Other: the patients ate a pizza that fermented for 8 hoursthe patients ate a pizza that fermented for 8 hours |
| Long fermented pizza | Experimental | Other: the patients ate a pizza that fermented for 24 hoursthe patients ate a pizza that fermented for 24 hours |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months
Key exclusion criteria (1 listed)
- Patients with HbA1c >8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the patients ate a pizza that fermented for 8 hoursPatients eat pizza prepared with controlled ingredients but fermented 8 hours | Other | Short fermented pizza |
| the patients ate a pizza that fermented for 24 hoursPatients eat pizza prepared with controlled ingredients but fermented 24 hours | Other | Long fermented pizza |
Primary outcome
Continuous glucose sensor data
Time frame: 11 hours
mmol/L
1 secondary outcome
Content of carbohydrates
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Results publication: PubMed 24160252Combet 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.
- Results publication: PubMed 15138460Gallus S, Tavani A, La Vecchia C. Pizza and risk of acute myocardial infarction. Eur J Clin Nutr. 2004 Nov;58(11):1543-6. doi: 10.1038/sj.ejcn.1601997.
- Results publication: PubMed 8462382Ahern 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. doi: 10.2337/diacare.16.4.578.
- Results publication: PubMed 26370244Mauseth 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. doi: 10.1177/1932296815602098.
- Results publication: PubMed 22013887Pankowska 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 2011 Oct 20.
- Results publication: PubMed 21355715De 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):483-7. doi: 10.1089/dia.2010.0163. Epub 2011 Feb 28.
- Results publication: PubMed 15857224Jones 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. doi: 10.1089/dia.2005.7.233.
- Derived from this study: PubMed 31335171Zanfardino A, Confetto S, Curto S, Cocca A, Rollato AS, Zanfardino F, Troise AD, Testa V, Bologna O, Stanco M, Piscopo A, Cohen O, Miraglia Del Giudice E, Vitaglione P, Iafusco D. Demystifying the Pizza Bolus: The Effect of Dough Fermentation on Glycemic Response-A Sensor-Augmented Pump Intervention Trial in Children with Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2019 Dec;21(12):721-726. doi: 10.1089/dia.2019.0191. Epub 2019 Aug 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the patients ate a pizza that fermented for 8 hours and the patients ate a pizza that fermented for 24 hours in people with Diabetes Mellitus, Type 1, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose sensor data (time frame: 11 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03748251, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.