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frequently sampled oral glucose tolerance testing, CGM & DXA for Cystic Fibrosis
N/A
Waitlist Available
Led By Katie Larson Ode, MD
Research Sponsored by Katie Larson Ode
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the data will be gathered at the study visit (one visit of 4+ per year over the 3 years of the study)-data analysis will occur at study close (approximately 2.5 to 3 years from the start of enrollment) data analysis and modeling will take 1-2 months
Awards & highlights
Study Summary
This trial is looking at whether they can predict which people with cystic fibrosis will experience clinical decline due to dysglycemia (high blood sugar).
Eligible Conditions
- Diabetes-Related Cystic Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the data will be gathered at the study visit (one visit of 4+ per year over the 3 years of the study)-data analysis will occur at study close (approximately 2.5 to 3 years from the start of enrollment) data analysis and modeling will take 1-2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the data will be gathered at the study visit (one visit of 4+ per year over the 3 years of the study)-data analysis will occur at study close (approximately 2.5 to 3 years from the start of enrollment) data analysis and modeling will take 1-2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
age- and sex-based nomograms for OGIS (oral glucose insulin sensitivity)
age- and sex-based nomograms for beta cell glucose sensitivity
Secondary outcome measures
evaluate the relationships between age and sex-based quantiles for OGIS and BMI z-score
evaluate the relationships between age and sex-based quantiles for OGIS and FEV-1
evaluate the relationships between age and sex-based quantiles for OGIS and the number of pulmonary exacerbations in the previous 12 months
+9 moreOther outcome measures
Correlation between CGM Time spent >140 mg/dl, and b-cell glucose sensitivity
Correlation between CGM Time spent >200 mg/dl, and b-cell glucose sensitivity
Correlation between CGM peak glucose and b-cell glucose sensitivity
+12 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: frequently sampled oral glucose tolerance testing, CGM & DXAExperimental Treatment3 Interventions
frequently sampled oral glucose tolerance testing will be performed in a one-time cross sectional visit + continuous glucose monitor will be placed after the visit and mailed back + a DXA scan will be done at the same visit
Group II: frequently sampled oral glucose tolerance testing and DXAExperimental Treatment2 Interventions
frequently sampled oral glucose tolerance testing will be performed in a one-time cross sectional visit + a DXA scan will be done at the same visit
Group III: frequently sampled oral glucose tolerance testingExperimental Treatment1 Intervention
frequently sampled oral glucose tolerance testing will be performed in a one-time cross sectional visit
Group IV: Frequently sampled oral glucose tolerance testing anc CGMExperimental Treatment2 Interventions
frequently sampled oral glucose tolerance testing will be performed in a one-time cross sectional visit + continuous glucose monitor will be placed after the visit and mailed back
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral glucose tolerance test
2013
Completed Phase 4
~2740
Continuous glucose monitoring
2019
N/A
~580
Dexa scan
2012
Completed Phase 4
~460
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Who is running the clinical trial?
Katie Larson OdeLead Sponsor
Katie Larson Ode, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
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