Clinical trial NCT02398383: Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes
Official title: Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cystic Fibrosis
Cystic Fibrosis Related Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucagon levels
timeFrame: baseline
Secondary outcomes:
measure: C-peptide levels
timeFrame: baseline
measure: C-peptide levels
timeFrame: 12 months
measure: Epinephrine levels
timeFrame: baseline
measure: Epinephrine levels
timeFrame: 12 months
measure: Norepinephrine levels
timeFrame: baseline
measure: Norepinephrine levels
timeFrame: 12 months
measure: Hypoglycemia unawareness scores
timeFrame: Baseline
measure: Hypoglycemia unawareness scores
timeFrame: 12 months
measure: GLP-1 and GIP levels
timeFrame: Baseline
measure: GLP-1 and GIP levels
timeFrame: 12 months
measure: Glucagon levels
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Bracha Goldsweig, MD
role: PRINCIPAL_INVESTIGATOR
References: