CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency and severity of hypoglycemic events
研究概览
简要总结
This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. Up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as HbA1c levels). The main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in PWT1D, and to address the role of CFTR variants as potential contributors to pancreatic insufficiency.
详细描述
In this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes.
Patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (EPI). EPI will be defined based on the levels of pancreatic enzymes (Amylase; lipase; and trypsinogen). As the prevalence of EPI in people living with type 1 diabetes (PWT1D) is ~50%, we expect roughly the same number of individuals into both groups (with or without EPI).
Variables :
Subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected.
Glucose variation will be assessed with a continuous glucose monitoring system for 1 month. Briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc..
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Living in Montreal
排除标准
- •Pregnancy,
- •Use of corticosteroid
- •Use of medication known to have a relevant impact on glycemic control.
结局指标
主要结局
Frequency and severity of hypoglycemic events
时间窗: 1 month
Continuous glucose monitoring will be used to assess glucose regulation
Exocrine pancreatic insufficiency
时间窗: Baseline
Blood levels of pancreatic enzymes will be measured
次要结局
未报告次要终点
研究者
Sylvie Lesage
Principal investigator
Ciusss de L'Est de l'Île de Montréal