Status:
COMPLETED
Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Cystic Fibrosis
Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 and Type 2 diabetes results when either the body does not make ...
Detailed Description
Insufficient incretin action has been associated with T2D. To study the possible link between insufficient incretin action and impaired insulin secretion in CFRD as in T2D, the present study will dete...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria
- Age ≥ 18y on date of consent
- Pancreatic insufficiency
- Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia
- For female subjects, negative urine pregnancy test at enrollment.
Exclusion
- Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia, (fasting glucose \> 126 mg/dL)
- History of clinically symptomatic pancreatitis within last year,
- Prior lung or liver transplant,
- Severe CF liver disease, as defined by portal hypertension,
- Fundoplication-related dumping syndrome,
- Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency),
- Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to enrollment,
- Treatment with oral or intravenous corticosteroids within 6 weeks of enrollment,
- Hemoglobin \<10g/dL, within 90 days of Visit 1 or at Screening,
- Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine clearance \< 50 mL/min (based on the Cockcroft-Gault formula) or potassium \> 5.5mEq/L on non-hemolyzed specimen,
- A history of anaphylaxis, angioedema or Stevens-Johnson syndrome,
- Inability to perform study specific procedures (MMTT, GPA),
- Subjects, who in study team opinion, may be non-compliant with study procedures.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01879228
Start Date
June 1 2013
End Date
March 1 2020
Last Update
March 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia and University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19194