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/35796669/Actively Recruiting
Led by University of Pennsylvania · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
N/A
Total Duration
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 mgdL, then stops as the test continues at 340 mgdL 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
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
P
Paola Alvarado
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University of Pennsylvania
Lead Sponsor
Children's Hospital of Philadelphia
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | GLP-1 Incretin Hormone | GIP Incretin Hormone |
|---|---|---|
| What is it? | A GLP-1 incretin hormone infusion administered during a glucose-potentiated arginine (GPA) test to assess beta-cell insulin response in adults with cystic fibrosis and pancreatic insufficiency. | A GIP incretin hormone infusion administered during the GPA test to evaluate beta-cell insulin response in the same trial population. |
| Role in trial | Evaluates the effects of GLP-1 on beta-cell function compared to GIP in cystic fibrosis with pancreatic insufficiency. | Acts as the comparator to GLP-1 in assessing beta-cell response in the same population. |
| Primary use or purpose | Experimental assessment of beta-cell insulin secretion in response to GLP-1 stimulation during GPA testing. | Experimental assessment of beta-cell insulin secretion in response to GIP stimulation during the GPA test. |
| How is it given or performed? | GLP-1 is administered intravenously as an infusion during the standardized GPA test session. | GIP is administered intravenously as an infusion during the GPA test session. |
| Published evidence status | Published trial data confirm that GLP-1 infusion increases insulin secretion during GPA testing in adults with cystic fibrosis and pancreatic insufficiency. | The same published trial demonstrates that GIP infusion had a lesser effect on insulin secretion during GPA testing in participants with cystic fibrosis. |
| Important limitations | Single-center design, small sample size, and limited generalizability to other cystic fibrosis populations or standard clinical settings. The intervention is for research use and not clinical care. | As with the GLP-1 arm, the study is limited by single-center, small-sample investigation and observational endpoints only. GIP use is investigational, not a clinical diagnostic or therapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Sarah C Nyirjesy, Amy J Peleckis, Jack N Eiel...
https://pubmed.ncbi.nlm.nih.gov/35796669/University of Pennsylvania
Lead Sponsor
Children's Hospital of Philadelphia
Collaborating Sponsor