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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Pennsylvania
Study ID
NCT04731272
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide 0.75Mg/0.5Ml Inj Pen — DRUG
    Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.

Study Details

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.

Key Dates

Start date
Jul 16, 2021
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Dulaglutide
    The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of dulaglutide therapy in the intervention period.
  • No Intervention: Observation
    The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of no intervention in the observation period.

Primary Outcome Measure

Early-phase insulin secretion [ Time Frame: 18 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of ColoradoAuroraColorado80045
Hannah Wessel
[email protected]
720-777-1880
Christine Chan, MD
[email protected]
720-777-0990
Christine Chan, MD (SUB_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Paola Alvarado, MS
[email protected]
215-746-2081
Cornelia Dalton-Bakes
[email protected]
215-746-2085
Michael Rickels, MD, MS (PRINCIPAL_INVESTIGATOR)
Andrea Kelly, MD, MS (PRINCIPAL_INVESTIGATOR)
Christine Chan, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Children's Hospital of Colorado· Aurora, COUniversity of Pennsylvania· Philadelphia, PA

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