Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Glycemic agreement between plasma glucose and CGM
研究概览
简要总结
The purpose of this study is to investigate the utility of a continuous glucose monitor device (CGM) in screening for cystic fibrosis related diabetes. The investigators will also study how fat deposition in the pancreas and liver impacts insulin production and response, as measured by a frequently sampled oral glucose tolerance test.
详细描述
Cystic Fibrosis Related Diabetes (CFRD) occurs in 20% of adolescents and 30-40% of adults with cystic fibrosis. CFRD is associated with reduced lung function, lower body mass index, and increased mortality. The CF Foundation recommends yearly Oral Glucose Tolerance Test (OGTT) for all CF patients beginning at age 10 years. Unfortunately adherence to screening recommendations is poor, with fewer than 50% of the eligible CF patients completing OGTT each year. Additionally, the OGTT has been criticized for poor reproducibility and for not accurately reflecting real-life glycemic excursions.
The FreeStyle Libre Pro is a blinded CGM that can record up to 14 days of home-living glucose data on one sensor. This quarter-sized device is placed on the upper arm and requires no fingerstick calibrations. Multiple studies have demonstrated the utility of CGM in CF patients, but no study has determined the utility of CGM in replicating the results of an OGTT. The use of CGM in CFRD screening has the potential to reduce screening burden, increase screening adherence and provide useful information about home glycemic excursions.
Pancreatic steatosis is common in CF with complete pancreatic fat replacement occurring in some cases. Pancreatic steatosis is also seen in patients with type 2 diabetes and may impact insulin secretion or the rate of beta cell decline. MRI is the most sensitive tool for detecting pancreatic steatosis. Ferrozzi described four patterns of pancreatic fat replacement in CF patients: (1) diffusely hyperintense with variable lobular pattern, (2) homogenous hyperintensity without lobular pattern, (3) hyperintense parenchyma with focal hypointensity, and (4) no structural or signal intensity changes. No studies have directly compared the degree of pancreatic steatosis with OGTT derived measures of insulin secretion or glycemic excursions on CGM.
Hepatic steatosis is also common in CF patients and has an unclear impact on insulin sensitivity. Outside of CF, hepatic steatosis is associated with insulin resistance.
This study has two aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis confirmed by sweat chloride or genetics
- •Pancreatic insufficient or pancreatic sufficient
- •No change in insulin status (either initiating or discontinuing) in the past 3 months
排除标准
- •CF liver disease with portal hypertension
- •Systemic glucocorticoid exposure the past 2 weeks (does not include inhaled)
- •Current pulmonary exacerbation treated with antibiotics
- •Baseline or current FEV1 <30% at time of recruitment
- •Transplant recipient
- •Pancreatic sufficient on insulin
- •Started CFTR modulator in the past 3 months
结局指标
主要结局
Glycemic agreement between plasma glucose and CGM
时间窗: 0 min-120min
Difference between blood glucose and CGM result will be calculated for each time point (0min, 30min, 60min, 90min, 120min).
Pancreatic Fat and Glycemic measures
时间窗: 0min-120min
Correlation between the degree of pancreatic fat replacement (Class 1-4 and fat fraction) and measures of beta cell function on glucose tolerance testing
次要结局
- Pancreatic Fat by Modulator Status(0min-120min)
- CGM results in CFRD vs. CFND(0 min-120min)
研究者
Katherine Kutney
Assistant Professor of Pediatric Endocrinology
University Hospitals Cleveland Medical Center