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Pizza Leavening and Postprandial Glycemia in Type 1 Diabetes (LEAVEN) (LEAVEN)

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ClinicalTrials.gov Identifier: NCT03619031
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

Brief Summary:
The purpose of this study is to compare in patients with type 1 diabetes the postprandial glucose response to the consumption of three types of pizza, obtained with different leavening techniques. The intervention will be preceded by a one-week run-in period during which participants will undergo continuous glucose monitoring (CGM) to optimize basal infusion rate and insulin-to-glycemic load ratio. According to a randomized crossover design, the participants will consume at home at dinner-time in three different days over a 3-week period in random order: 1) a long-leavened pizza, composed of sourdough and a flour mix; 2) a short-leavened pizza, composed of sourdough and a flour mix; 3) a traditional pizza, composed of brewer's yeast and refined wheat flour, used as control. Over the three experimental weeks, participants will undergo CGM, wearing their sensors 7 days/week. The results of this study will allow optimizing insulin therapy based on the different characteristics of pizza in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce their risk of developing chronic diabetes complications.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: LONG LEAVENING Other: SHORT LEAVENING Other: TRADITIONAL Not Applicable

Detailed Description:

Pizza is a typical food from Southern Italy. Its consumption is spreading worldwide. However, eating pizza is often challenging for type 1 diabetes patients due to its high glycemic index and the sustained and prolonged postprandial hyperglycaemia. Therefore, modifications of the composition and manufacturing processes able to improve the effects of pizza on postprandial blood glucose response would be well accepted.

The purpose of this study is to compare in patients with type 1 diabetes the postprandial glucose response to the consumption of three types of pizza, obtained with different leavening techniques.

Patients with type 1 diabetes treated with continuous subcutaneous insulin infusion for at least 6 months and HbA1c less than 8.0%, will be recruited at the diabetes care unit of the Federico II University teaching hospital.

The intervention will be preceded by a one-week run-in period during which participants will undergo continuous glucose monitoring (CGM) to optimize basal infusion rate and insulin-to-glycemic load ratio. Then, according to a randomized crossover design, participants will consume at home at dinner-time in random order in three different days over a 3-week period:1) a long-leavened (60 h) pizza composed of sourdough and a flour mix; 2) a short-leavened (5 h) pizza composed of sourdough and a flour mix; 3) a traditional pizza composed of brewer's yeast and refined wheat flour. Over the three experimental weeks, participants will undergo CGM, wearing their sensors 7 days/week.

The pizza- meals will be similar in energy content and macronutrient composition. The pizza dough will be prepared in a specialized factory and kept under vacuum until use. Participants will be also provided with tomato sauce and extra-virgin olive oil in the exact amount needed to prepare pizza.

The test meal will be postponed in case of premeal blood glucose levels outside the 90-150 mg/dl range or a rapid decrease/increase of glucose levels (above 1 mg/dl per min) during the previous 60 min according to CGM measurement, Pre-meal insulin doses, will be calculated based on the individual insulin-to-glycemic load ratio and will be the same on all three occasions.

At the end of the experimental period, data from CGM and insulin pump will be downloaded by dedicated informatics platforms. Participants will use the CGM system integrated with their insulin pump, i.e., the one they are accustomed to.

The primary outcome will be the postprandial blood glucose incremental area under the curve (AUC). The secondary outcomes will be blood glucose peak and time to blood glucose peak. Both primary and secondary outcomes will be evaluated by general linear model for repeated-measures ANOVA .

The results of this study will allow the optimization of insulin therapy based on the different characteristics of pizza, in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce their risk of developing chronic diabetes complications. These complications involve severe disability for patients and huge costs for the community. Moreover, considering the large consumption of pizza, the identification of changes in its composition determining a more advantageous postprandial metabolic profile could also bring benefits to the health of the general population, reducing the incidence of chronic diseases such as type 2 diabetes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pizza Leavening Process on Postprandial Glucose Response in Patients With Type 1 Diabetes
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LONG LEAVENING
Acute test meal
Other: LONG LEAVENING
a long-leavened (60 h) pizza composed of sourdough and a flour mix.

Experimental: SHORT LEAVENING
Acute test meal
Other: SHORT LEAVENING
a short-leavened (5 h) pizza composed of sourdough and a flour mix.

Active Comparator: TRADITIONAL
Acute test meal
Other: TRADITIONAL
a short-leavened (5 h) pizza composed of brewer's yeast and 00 flour.




Primary Outcome Measures :
  1. Postprandial glucose response (AUC) [ Time Frame: 2 hours ]
    Area under the curve

  2. Postprandial glucose response (AUC) [ Time Frame: 8 hours ]
    Area under the curve


Secondary Outcome Measures :
  1. Blood glucose peak [ Time Frame: 8 hours ]
    The maximum glucose excursion starting from the fasting values in the hours following the meal

  2. Time to blood glucose peak [ Time Frame: 8 hours ]
    The time at which the maximum glucose excursion occurred in the hours following the meal.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment with continuous subcutaneous insulin infusion for at least 6 months
  • HbA1c less than 8.0% (64 mmol/mol)

Exclusion Criteria:

  • Pregnancy
  • Celiac disease
  • Serious microvascular and macrovascular diabetes complications including autonomic neuropathy possibly influencing gastric emptying
  • Any other chronic or acute disease apart diabetes seriously affecting health status

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): NCT03619031


Locations
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Italy
Department of Clinical Medicine and Surgery
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University

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Responsible Party: rivellese angela, Full Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03619031     History of Changes
Other Study ID Numbers: 107/18
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 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 rivellese angela, Federico II University:
type 1 diabetes
postprandial glycemia
pizza leavening

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