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

Diabetes Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Abnormal Glucose Tolerance
• Cystic Fibrosis
• Diabetes
• Exocrine Pancreatic Insufficiency
• Fibrosis
• Glucose Intolerance
• Pancreatic Insufficiency

• NCT number: NCT04731272
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Paola Alvarado, MS
• Phone: 215-746-2081
• Email: Paola.Alvarado@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2021
• Completion date: June 30, 2027