Status:
COMPLETED
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Lead Sponsor:
Arbelaez, Ana Maria
Collaborating Sponsors:
Washington University School of Medicine
National Institutes of Health (NIH)
Conditions:
Cystic Fibrosis Related Diabetes
Pancreatic Insufficiency
Eligibility:
All Genders
12-24 years
Phase:
NA
Brief Summary
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of ...
Detailed Description
As people with Cystic Fibrosis (CF) are living well into adulthood new complications are arising. CF-Related Diabetes (CFRD) has emerged as a major complication. Years prior to the diagnosis of CFRD, ...
Eligibility Criteria
Inclusion
- Male or females 12 -24 years old
- Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
- Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose \<126 mg/dl and 2 hour: 140 - 199 mg/dl or \>200 mg/dl.
- Weight must be stable within 5% for 3 months prior to initiation visit
- Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines
Exclusion
- Patients receiving growth hormone therapy or taking insulin
- Patients with evidence of liver dysfunction
- Patients who are status-post lung or liver transplantation
- Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
- Patients with active ABPA on steroids
- Patients taking medications that affect glucose metabolism or contraindicated with repaglinide
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00763412
Start Date
November 1 2006
End Date
January 1 2013
Last Update
June 5 2017
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110