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 study tests whether a GLP-1 receptor agonist medication (dulaglutide, an injectable drug used for type 2 diabetes) can improve blood sugar control in people with cystic fibrosis (CF) who have abnormal glucose tolerance or cystic fibrosis-related diabetes (CFRD). People with CF often develop diabetes because the thick mucus in the pancreas destroys insulin-producing cells. Better blood sugar management is important because poor glucose control is associated with worse lung function and outcomes in CF. Participants will inject dulaglutide weekly and be carefully monitored for blood sugar levels and any side effects. The study includes detailed metabolic testing to understand how the drug affects insulin secretion in CF. You may be eligible if: - You are 18 years or older with a confirmed CF diagnosis - You have pancreatic insufficiency requiring enzyme supplements - You have abnormal glucose tolerance, CF-related diabetes (without fasting hyperglycaemia), or CFRD with a C-peptide level of 1.2 ng/mL or more and HbA1c at or below 8% - You are willing and able to give weekly self-injections You may NOT be eligible if: - Your BMI is below 19 - You have a personal or family history of medullary thyroid cancer or MEN2 syndrome - You are pregnant or breastfeeding - You have had a pulmonary exacerbation requiring IV antibiotics within the past 4 weeks - You have had a prior lung, liver, or solid organ transplant - You have clinically symptomatic pancreatitis in the past year or severe CF liver disease - You have a known allergy to any GLP-1 agonist Talk to your doctor to see if this trial is right for you.

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

View Full Details on ClinicalTrials.gov

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NCT04731272


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