跳至主要内容
临床试验/NCT03619031
NCT03619031已完成不适用

Effects of Pizza Leavening Process on Postprandial Glucose Response in Patients With Type 1 Diabetes

Federico II University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Postprandial glucose response (AUC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

LONG LEAVENING

Experimental

Acute test meal

干预措施: LONG LEAVENING (Other)

SHORT LEAVENING

Experimental

Acute test meal

干预措施: SHORT LEAVENING (Other)

TRADITIONAL

Active Comparator

Acute test meal

干预措施: TRADITIONAL (Other)

结局指标

主要结局

Postprandial glucose response (AUC)

时间窗: 8 hours

Area under the curve

次要结局

  • Blood glucose peak(8 hours)
  • Time to blood glucose peak(8 hours)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

rivellese angela

Full Professor

Federico II University

研究点 (2)

Loading locations...

相似试验