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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Other 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 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any regional facilities doing this research initiative?

"This health research is in progress at 4 medical centres including Iowa City, Aurora, and Saint Louis as well as another quartet of treatment sites. To limit travel requirements if enrolled, it is best to select the closest trial site."

Answered by AI

Is this trial still welcoming participants?

"According to clinicaltrials.gov, this particular medical trial is no longer recruiting volunteers and has not been updated since December 28th 2021. Despite that fact, the same website indicates that 417 other trials are actively searching for participants at this time."

Answered by AI

What are the primary goals of this clinical research endeavor?

"This clinical trial's primary goal is to create age- and sex-based nomograms for oral glucose insulin sensitivity (OGIS), which will be evaluated over a period of 3 years via 4+ study visits. Post-data collection, modelling and analysis should take 1-2 months. Secondary objectives include quantile regression studies that assess the relationship between beta cell glucose sensitivity and FEV-1 score; OGIS and FEV-1 score; as well as insulin levels against the number of pulmonary exacerbations experienced in the past 12 months."

Answered by AI

Recent research and studies

Diabetes CareJournal

A Model-based Method for Assessing Insulin Sensitivity from the Oral Glucose Tolerance Test

Mari, Andrea, Giovanni Pacini, Elaine Murphy, Bernhard Ludvik, and John J. Nolan. 2001. “A Model-based Method for Assessing Insulin Sensitivity from the Oral Glucose Tolerance Test”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.24.3.539.

The Journal of Clinical Endocrinology & MetabolismJournal

Age- and Sex-dependent Distribution of Ogtt-related Variables in a Population of Cystic Fibrosis Patients

Battezzati, Alberto, Giorgio Bedogni, Laura Zazzeron, Andrea Mari, Pier Maria Battezzati, Gianfranco Alicandro, Simona Bertoli, and Carla Colombo. 2015. “Age- and Sex-dependent Distribution of Ogtt-related Variables in a Population of Cystic Fibrosis Patients”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2015-1512.

Diabetes, Obesity and MetabolismJournal

Β-cell Function Assessment from Modelling of Oral Tests: An Effective Approach

Mari, A., and E. Ferrannini. 2008. “Β-cell Function Assessment from Modelling of Oral Tests: An Effective Approach”. Diabetes, Obesity and Metabolism. Wiley. doi:10.1111/j.1463-1326.2008.00946.x.

clinicaltrials.govStudy