Status:
TERMINATED
Prevention of Cystic Fibrosis Diabetes
Lead Sponsor:
Emory University
Conditions:
Cystic Fibrosis
Prediabetes
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worse...
Detailed Description
This was a double-blind, placebo-controlled, multicenter study intending to enroll 118 CF subjects aged 13 years of age or older who have high risk prediabetes. High risk prediabetes was defined durin...
Eligibility Criteria
Inclusion
- Aged 13 years of age or older at the time of enrollment
- Diagnosis of cystic fibrosis (CF) confirmed by pilocarpine iontophoresis sweat chloride measurements and/or genotyping
- Clinically stable with no lower respiratory tract exacerbation requiring intravenous antibiotics in the three weeks prior to enrollment
- On a stable clinical treatment regimen for at least three weeks prior to enrollment
- Male or female. If female, is not lactating and has a negative pregnancy test at screening. If female of child bearing potential, willing to practice effective birth control (i.e. a method known to decrease the risk of pregnancy to less than 1%)
- Able to understand and provide informed consent
- Willing and able to comply with the study schedule and testing
- High risk prediabetes as defined by high-risk impaired fasting glucose levels of 110-125 mg/dl and/or a 2-hour plasma glucose level of 140 to 199 mg/dl found on an Oral Glucose Tolerance Test performed at screening 8 weeks or less before enrollment
- Available by telephone
- Has literacy and language skills required to fill out study material
Exclusion
- Diagnosed with CF related diabetes
- Chronic heart failure with New York Heart Association (NYHA) class III/IV, ejection fraction less than 25%, or receiving digoxin
- Liver disease as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) three times above the upper limit of normal.
- Serum creatinine greater than 1.3 mg/dl for males and greater than 1.1 mg/dl for females or receiving chronic dialysis
- Taking chronic oral or intravenous glucocorticosteroids during the past month
- On insulin therapy during the past month
- CF lung disease severe enough to require daytime chronic oxygen therapy via nasal cannula during the past month
- Unable to perform pulmonary function testing
- History of any illness or condition that, in the opinion of the sponsor might confound the results of the study or pose an additional risk in administering study drug to the subject
- Post lung or liver transplant
- Listed and awaiting organ transplant
- Current drug or alcohol dependency
- Participating in another clinical drug trial or past participant within 30 days of enrollment
- Pancreatic sufficient
- History of acute pancreatitis as documented by characteristic clinical manifestations and elevation of serum amylase and lipase within the last 2 years.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00967798
Start Date
May 1 2010
End Date
December 31 2017
Last Update
June 25 2018
Active Locations (3)
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1
Emory University and Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
2
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205