Effects of GLP-1 and GIP on Islet Function in Glucose-Intolerant, Pancreatic-Insufficient Cystic Fibrosis.
Sarah C Nyirjesy, Amy J Peleckis, Jack N Eiel...
https://pubmed.ncbi.nlm.nih.gov/35796669Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID01851694
Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis
Led by University of Pennsylvania · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the complex relationship between cystic fibrosis (CF) and a form of diabetes known as cystic fibrosis related diabetes (CFRD). This condition has features similar to both type 1 and type 2 diabetes, but CF patients may exhibit different symptoms. The study aims to better understand the mechanisms behind CFRD and explore how incretin hormones, which stimulate insulin production, may affect insulin release in CF patients. Participants will receive infusions of two incretin hormones, GLP-1 and GIP, during glucose pancreatic assessment (GPA) tests. The incretin infusion starts 30 minutes before the GPA test and continues for 90 minutes during the test at a glucose level of 230 mg/dL, then stops as the test continues at 340 mg/dL without incretin. Each participant will also undergo the same GPA test with a placebo infusion for comparison. The study includes CF patients with normal glucose tolerance and non-CF control participants. During the study, participants undergo GPA tests to measure the second-phase insulin response, which reflects how beta cells in the pancreas release insulin. The research team will monitor insulin secretion changes over five hours, comparing responses during incretin and placebo infusions. The study is randomized and quadruple-blinded, ensuring unbiased results. Participants will be closely observed for safety and adherence to study procedures throughout the process.
CONDITIONS
Brief Title
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cystic fibrosis by positive sweat test or CFTR mutation analysis
- Age 18 years or older at the time of consent
- Pancreatic insufficiency
- Recent oral glucose tolerance test showing indeterminate glucose tolerance, impaired glucose tolerance, or cystic fibrosis related diabetes without fasting high blood sugar
- For female participants, a negative urine pregnancy test at enrollment
- Control subjects must have no history of cystic fibrosis
- Control subjects must be 18 years or older
- Control subjects must have recent oral glucose tolerance test consistent with normal glucose tolerance
- Control female subjects must have a negative urine pregnancy test at enrollment
You will not qualify if you...
- Diagnosis of non-cystic fibrosis diabetes or cystic fibrosis related diabetes with fasting high blood sugar (fasting glucose >126 mg/dL)
- Clinically symptomatic pancreatitis within the last year
- Prior lung or liver transplant
- Severe cystic fibrosis liver disease, defined by portal hypertension
- Fundoplication-related dumping syndrome
- Non-cystic fibrosis related or unstable medical conditions
- Acute illness or therapy changes within 6 weeks before study procedures
- Use of oral or intravenous corticosteroids within 6 weeks before study
- Hemoglobin less than 10 g/dL within 90 days before screening
- Abnormal kidney function within 90 days before screening
- Inability to perform study-specific procedures
- Expected non-compliance with study procedures
- Control subjects exposed to GIP only with history of pancreatitis or liver disease
- Control subjects with elevated serum amylase or lipase more than 1.5 times the upper limit of normal within 90 days before testing
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day procedures
Participants receive infusions of incretin hormones (GLP-1 or GIP) or placebo during GPA tests to measure insulin release from beta cells.
2 infusion visits (in-person) with each participant receiving both hormone and placebo infusions on separate occasions
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia and University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19060
Actively Recruiting
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Research Team
P
Paola Alvarado
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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