Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes

Condition(s) targeted: Cystic Fibrosis; Cystic Fibrosis Related Diabetes

Intervention: Oral Glucose Tolerance Test (Other); Mixed Meal Tolerance Test (Other); Hypoglycemic Clamp (Other)

Phase: Phase 0

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Bracha Goldsweig, MD, Principal Investigator, Affiliation: Yale University

Overall contact:
Lori Carria, Phone: 203-737-3595, Email: lori.carria@yale.edu

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.

Official title: Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Glucagon levels

Secondary outcome:

C-peptide levels

C-peptide levels

Epinephrine levels

Epinephrine levels

Norepinephrine levels

Norepinephrine levels

Hypoglycemia unawareness scores

Hypoglycemia unawareness scores

GLP-1 and GIP levels

GLP-1 and GIP levels

Glucagon levels

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.

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Lori Carria, Phone: 203-737-3595, Email: lori.carria@yale.edu

Yale New Haven Hospital, New Haven, Connecticut 06511, United States; Recruiting

Starting date: March 2015
Last updated: March 19, 2015