Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Measurement of the sensitivity and the specificity of HOMA-%IR (homeostasis model assessment index of insulin resistance) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system.
研究概览
简要总结
Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.
The aim of this study is to compare sensitivity and specificity of different methods for GM monitoring in children and adolescents with CF.
Continuous GM system (CGMS) will be used as the reference method. Results will be compared to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT), homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C). Patients will be classified into three groups according to CGMS: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L.
- •Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation.
- •Subjects will be pancreatic insufficient.
- •Subjects must have a forced expiratory volume 1 (FEV1)> 40 % of predicted normal for age, sex and height at the screening visit.
- •Stable CF disease as judged by the investigator
排除标准
- •Subjects with glucose intolerance abnormalities
- •Subjects with pulmonary exacerbation within 4 weeks before screening
- •History of lung or hepatic transplantation or awaiting transplantation
研究组 & 干预措施
Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
干预措施: HGPIV diagnosis test (Procedure)
Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
干预措施: HOMAR-IR diagnosis test (Procedure)
Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
干预措施: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT (Other)
结局指标
主要结局
Measurement of the sensitivity and the specificity of HOMA-%IR (homeostasis model assessment index of insulin resistance) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system.
时间窗: Day 3
Measurement of the sensitivity and the specificity of IGTT (intravenous glucose tolerance test) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system
时间窗: Day 3
次要结局
- Measurement of the prevalence of diabetes mellitus.(Day 3)
- Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).(Day 3)
- Measurement of glucose intolerance(Day 3)
- Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).(Day 3)