Pizza Leavening and Postprandial Glycemia in Type 1 Diabetes (LEAVEN)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): LONG LEAVENING; SHORT LEAVENING; TRADITIONAL
Intervention type(s): Other; Other; Other
Intervention description(s): a long-leavened (60 h) pizza composed of sourdough and a flour mix.; a short-leavened (5 h) pizza composed of sourdough and a flour mix.; a short-leavened (5 h) pizza composed of brewer's yeast and 00 flour.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 1 diabetes; postprandial glycemia; pizza leavening