Actively Recruiting
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
Led by University of Pennsylvania · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
708 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
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear. The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients. Enrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups: * Cystic Fibrosis participants with normal glucose tolerance * Non-Cystic Fibrosis controls
CONDITIONS
Official Title
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
Who Can Participate
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 consent
- Pancreatic insufficiency
- Recent oral glucose tolerance test showing Indeterminate-GT, IGT, CFRD without fasting hyperglycemia, or established CFRD without fasting hyperglycemia
- Negative urine pregnancy test at enrollment for females
- Control subjects must have no history of cystic fibrosis
- Control subjects must be 18 years or older at consent
- Control subjects must have recent oral glucose tolerance test consistent with normal glucose tolerance
- Negative urine pregnancy test at enrollment for female control subjects
You will not qualify if you...
- Diagnosed with non-cystic fibrosis diabetes or cystic fibrosis related diabetes with fasting hyperglycemia (fasting glucose >126 mg/dL)
- Symptomatic pancreatitis within the last year
- Prior lung or liver transplant
- Severe cystic fibrosis liver disease with portal hypertension
- Fundoplication-related dumping syndrome
- Unstable or non-cystic fibrosis related medical conditions as judged by investigator
- Acute illness or therapy changes including antibiotics within 6 weeks before study
- Treatment with oral or intravenous corticosteroids within 6 weeks before study
- Hemoglobin less than 10 g/dL within 90 days before study or at screening
- Abnormal kidney function within 90 days before study or at screening
- Unable to perform study procedures (MMTT, GPA)
- Considered potentially non-compliant by study team
- For control subjects exposed to GIP only: history of pancreatitis, liver disease, any condition confounding study or posing risk, hemoglobin <10 g/dL, abnormal renal function, inability to perform procedures, potential non-compliance, or elevated serum amylase or lipase >1.5 times upper limit of normal within 90 days before study
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia and University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19060
Actively Recruiting
Research Team
P
Paola Alvarado
CONTACT
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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