RecruitingPhase 2NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial


Sponsor

University of Pennsylvania

Enrollment

30 participants

Start Date

Jul 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing whether a weekly injection of dulaglutide — a GLP-1 receptor agonist medication — can improve early insulin secretion and blood sugar control in people with cystic fibrosis (CF) who have abnormal glucose tolerance or CF-related diabetes (CFRD). Diabetes is a major complication of CF in people with pancreatic insufficiency and is linked to worse lung and overall health outcomes. Adults (18+) with confirmed CF, pancreatic insufficiency, and abnormal glucose results on a tolerance test — and who are willing to take a weekly subcutaneous injection — are eligible, though those with a BMI under 19, recent lung exacerbation, or prior organ transplant are excluded. Participation involves weekly injections for several weeks, a mixed-meal tolerance test, and regular monitoring for glucose, safety, and lung-related outcomes. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDulaglutide 0.75Mg/0.5Ml Inj Pen

Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.


Locations(2)

Children's Hospital of Colorado

Aurora, Colorado, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT04731272


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