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

Brief description of study

Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced -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 -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.

Detailed description of study

The study entails:

1. One Oral Glucose Tolerance Test during screening visit, labs, and medical history review. ($75.00)

2. Four Mixed Meal Tolerance Test. ($200.00 per MMTT)

3. Bi-weekly surveys for the duration of the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Cystic Fibrosis
Age: Between 18 Years - 50 Years
Gender: All

1. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.

2. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.

3. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL)

4. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT)

5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of dulaglutide or observation administration; oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable

6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Updated on 09 Mar 2024. Study ID: 848357

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