Actively Recruiting
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
Led by University of Pennsylvania · Updated on 2025-04-27
30
Participants Needed
2
Research Sites
310 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced β-cell mass contributes to the insulin secretory defects that characterizes cystic fibrosis-related diabetes (CFRD), other modifiable determinants appear operative in the emergence and progression of abnormal glucose tolerance towards diabetes. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.
CONDITIONS
Official Title
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 6518 years on date of consent
- Confirmed diagnosis of cystic fibrosis by positive sweat test or CFTR mutation analysis per Cystic Fibrosis Foundation criteria
- Pancreatic insufficiency requiring pancreatic enzyme replacement
- Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD without fasting hyperglycemia or with fasting hyperglycemia meeting specific HbA1c and C-peptide levels
- Ability to take subcutaneous medication and willingness to adhere to weekly administration and complete study procedures
- For females of reproductive potential: use of highly effective contraception starting at least 1 month before screening, during study, and for 6 weeks after study drug or observation period
You will not qualify if you...
- Body mass index (BMI) less than 19 kg/m2
- First-degree atrioventricular block or other cardiac conduction or structural heart defects
- Pregnancy or breastfeeding; negative urine pregnancy test required at enrollment
- Known allergy to any GLP-1 agonist or history of severe hypersensitivity reactions
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
- Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks before study procedures
- Current nausea, vomiting, or diarrhea
- Diagnosis of non-CF diabetes (e.g., type 1 diabetes) or CFRD with fasting hyperglycemia unless using prandial insulin or repaglinide
- History of symptomatic pancreatitis within the last year
- Prior lung, liver, or other solid organ transplant
- Severe cystic fibrosis liver disease with portal hypertension
- History of fundoplication-related dumping syndrome
- Hemoglobin less than 10 g/dL within 90 days before study procedures
- Abnormal kidney function within 90 days before study procedures (creatinine >2x upper limit of normal or potassium >5.5 mEq/L)
- Any illness or condition that might affect study results or increase risk to the participant according to the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Paola Alvarado, MS
CONTACT
C
Cornelia Dalton-Bakes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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