Beta-cell Response to Incretin Hormones in Cystic Fibrosis
This study is looking into how the body's insulin-producing cells (beta-cells) respond to certain hormones in people with cystic fibrosis (CF) and pancreatic insufficiency. Specifically, it's testing if giving GLP-1 or GIP (incretin hormones) can improve insulin release in people with cystic fibrosis related diabetes (CFRD). You might be able to join if you are 18 or older, have a confirmed diagnosis of CF, pancreatic insufficiency, and a specific type of CFRD or pre-diabetes. The main goal is to measure how much insulin your body releases after receiving these hormones compared to a placebo (a salt solution). The study is currently unclear on its status.
- Study design
- This is an interventional study planning to enroll 45 participants. It is a blinded study, meaning neither you nor the research team will know which treatment you are receiving until after the study.
- What's involved
- Each participant will receive GLP-1 infusion and a placebo infusion during a GPA test, and GIP infusion and placebo during a GPA test.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, second-phase insulin response, is measured at 5 hours.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael R. Rickels, MD, MS · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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What this trial measures
- Second-phase insulin response during GPA test5 hours
The key endpoint of interest will be the change in second phase insulin response derived from the Glucose-Potentiated Arginine (GPA) test. The GPA test will measure insulin (and other glucose controlling hormones) which will be a measure of pancreatic endocrine function in response to injection of arginine. Arginine is a naturally occurring amino acid (substance) in the body. It will be given in the veins to make the pancreas secrete insulin. After the first injection of arginine, a glucose infusion will be started in order to raise the level of sugar in the blood to 230 mg/dl. Once the level is achieved, arginine will be injected again and blood samples are measured. After a 2 hour break, the glucose infusion will be started to achieve a blood sugar of 340mg/dl and arginine injection will be repeated. Comparison of responses with incretin vs. placebo will be performed using statistical methods, specifically, paired t-test or Wilcoxon matched pair test.