Status:
COMPLETED
Glycemic Monitoring in Cystic Fibrosis
Lead Sponsor:
University of Colorado, Denver
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-25 years
Brief Summary
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Incr...
Eligibility Criteria
Inclusion
- Healthy controls (n=45) -
- Age 10-25 years
- BMI \<85th percentile
- Baseline health at enrollment
- CF controls (n=45) -
- Age 10-25 years
- Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype)
- CF prediabetes \& CFRD (n=70)
- Age 10-25 years
- Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- History of abnormal oral glucose tolerance testing (2h-glucose \>140, fasting plasma glucose \>100,1hr glucose \>200)
- If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months
Exclusion
- Healthy controls -
- Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
- BMI ≥85th percentile
- Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
- Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)
- Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)
- Pregnancy
- CF participants -
- Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
- Varying doses of medication affecting glucose metabolism in the past 3 months
- Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks
- Pregnancy
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT02211235
Start Date
August 1 2014
End Date
May 16 2018
Last Update
March 22 2023
Active Locations (1)
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1
Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, United States, 80045