Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Glucagon levels
研究概览
简要总结
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
详细描述
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of CF by clinical or genetic determination
- •Normal glucose tolerance or CFRD
- •Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible
排除标准
- •Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
- •Use of any oral diabetes medications
- •Subjects who are pregnant/lactating
- •Subjects with poor compliance with pancreatic enzyme replacement therapy
- •Control Subjects:
- •Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be >12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be >110 mg/dL will not be continued in the study.
结局指标
主要结局
Glucagon levels
时间窗: baseline
Glucagon levels in response to to a mixed meal stimulus
次要结局
- Epinephrine levels(12 months)
- C-peptide levels(12 months)
- Hypoglycemia unawareness scores(12 months)
- Glucagon levels(12 months)
- Norepinephrine levels(12 months)
- GLP-1 and GIP levels(12 months)