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Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes

2020年6月24日更新者：Yale University

Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

阶段

第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Connecticut
  - New Haven、Connecticut、美国、06511
    - Yale New Haven Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年至 45年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：基础科学
分配：非随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：CF with Normal Glucose Tolerance Individuals with CF without cystic fibrosis related diabetes	其他：Oral Glucose Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test. 其他：Mixed Meal Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes. 其他：Hypoglycemic Clamp All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
实验性的：Cystic Fibrosis Related Diabetes Individuals with cystic fibrosis and cystic fibrosis related diabetes	其他：Oral Glucose Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test. 其他：Mixed Meal Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes. 其他：Hypoglycemic Clamp All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
有源比较器：Control Age matched control subjects	其他：Oral Glucose Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test. 其他：Mixed Meal Tolerance Test Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes. 其他：Hypoglycemic Clamp All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Glucagon levels 大体时间：baseline	Glucagon levels in response to to a mixed meal stimulus	baseline

次要结果测量

结果测量	措施说明	大体时间
C-peptide levels 大体时间：baseline	C-peptide levels during oral glucose tolerance test and mixed meal tolerance test	baseline
C-peptide levels 大体时间：12 months	C-peptide levels during oral glucose tolerance test and mixed meal tolerance test	12 months
Epinephrine levels 大体时间：baseline	Epinephrine and norepinephrine levels during hypoglycemic clamp	baseline
Epinephrine levels 大体时间：12 months	Epinephrine and norepinephrine levels during hypoglycemic clamp	12 months
Norepinephrine levels 大体时间：baseline	norepinephrine levels during hypoglycemic clamp	baseline
Norepinephrine levels 大体时间：12 months	norepinephrine levels during hypoglycemic clamp	12 months
Hypoglycemia unawareness scores 大体时间：Baseline	Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey	Baseline
Hypoglycemia unawareness scores 大体时间：12 months	Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey	12 months
GLP-1 and GIP levels 大体时间：Baseline	GLP-1 and GIP levels in response to mixed meal stimulus	Baseline
GLP-1 and GIP levels 大体时间：12 months	GLP-1 and GIP levels in response to mixed meal stimulus	12 months
Glucagon levels 大体时间：12 months	Glucagon levels in response to to a mixed meal stimulus and difference from baseline	12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yale University

调查人员

首席研究员：Bracha Goldsweig, MD、Yale University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (实际的)

2017年6月22日

研究完成 (实际的)

2017年6月22日

研究注册日期

首次提交

2015年1月22日

首先提交符合 QC 标准的

2015年3月19日

首次发布 (估计)

2015年3月25日

研究记录更新

最后更新发布 (实际的)

2020年6月26日

上次提交的符合 QC 标准的更新

2020年6月24日

最后验证

2020年6月1日

Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes