Status:
RECRUITING
Beta-cell Response to Incretin Hormones 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 (T1D) and Type 2 (T2D) diabetes results when either the body do...
Detailed Description
Previously, cystic fibrosis related diabetes (CFRD) was considered to be a consequence of damage to the pancreas therefore the cells contained in the pancreas--i.e.--islets that house beta cells, whic...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,
- Age greater than or equal to 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.
- Control Subjects:
- No history of cystic fibrosis.
- Age ≥ 18y on date of consent.
- Recent OGTT consistent with NGT.
- 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 greater than126 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 study procedures
- Treatment with oral or intravenous corticosteroids within 6 weeks of study
- Hemoglobin less than10g/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 greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen
- Inability to perform study specific procedures (MMTT, GPA)
- Subjects, who in study team opinion, may be non-compliant with study procedures.
- Control Subjects who will be exposed to GIP only:
- History of clinically symptomatic pancreatitis.
- History of liver disease.
- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
- Hemoglobin \<10g/dL, within 90 days of GPA test or at Screening.
- Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \> 2x upper limit of normal (ULN) or potassium \> 5.5mEq/L on non-hemolyzed specimen.
- Inability to perform study specific procedures (MMTT, GPA).
- subjects, who in study team opinion, may be non-compliant with study procedures.
- elevation of serum amylase or lipase \> 1.5x ULN within 90 days of GPA test.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01851694
Start Date
May 1 2013
End Date
December 1 2025
Last Update
January 31 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia and University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19060