Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis (CFCGM)

May 16, 2022 updated by: Katherine Kutney, University Hospitals Cleveland Medical Center
The purpose of this study is to investigate the utility of a continuous glucose monitor device (CGM) in screening for cystic fibrosis related diabetes. The investigators will also study how fat deposition in the pancreas and liver impacts insulin production and response, as measured by a frequently sampled oral glucose tolerance test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cystic Fibrosis Related Diabetes (CFRD) occurs in 20% of adolescents and 30-40% of adults with cystic fibrosis. CFRD is associated with reduced lung function, lower body mass index, and increased mortality. The CF Foundation recommends yearly Oral Glucose Tolerance Test (OGTT) for all CF patients beginning at age 10 years. Unfortunately adherence to screening recommendations is poor, with fewer than 50% of the eligible CF patients completing OGTT each year. Additionally, the OGTT has been criticized for poor reproducibility and for not accurately reflecting real-life glycemic excursions.

The FreeStyle Libre Pro is a blinded CGM that can record up to 14 days of home-living glucose data on one sensor. This quarter-sized device is placed on the upper arm and requires no fingerstick calibrations. Multiple studies have demonstrated the utility of CGM in CF patients, but no study has determined the utility of CGM in replicating the results of an OGTT. The use of CGM in CFRD screening has the potential to reduce screening burden, increase screening adherence and provide useful information about home glycemic excursions.

Pancreatic steatosis is common in CF with complete pancreatic fat replacement occurring in some cases. Pancreatic steatosis is also seen in patients with type 2 diabetes and may impact insulin secretion or the rate of beta cell decline. MRI is the most sensitive tool for detecting pancreatic steatosis. Ferrozzi described four patterns of pancreatic fat replacement in CF patients: (1) diffusely hyperintense with variable lobular pattern, (2) homogenous hyperintensity without lobular pattern, (3) hyperintense parenchyma with focal hypointensity, and (4) no structural or signal intensity changes. No studies have directly compared the degree of pancreatic steatosis with OGTT derived measures of insulin secretion or glycemic excursions on CGM.

Hepatic steatosis is also common in CF patients and has an unclear impact on insulin sensitivity. Outside of CF, hepatic steatosis is associated with insulin resistance.

This study has two aims:

Aim 1: Determine how closely the FreeStyle Libre Pro CGM can replicate the results of an in-clinic oral glucose tolerance test.

Aim 2: Explore whether pancreatic and hepatic steatosis correlated with insulin secretion and sensitivity in CF patients.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cystic fibrosis will be recruited from the LeRoy W. Matthews CF Center at UH Cleveland Medical Center.

Description

Inclusion Criteria:

  • Cystic fibrosis confirmed by sweat chloride or genetics
  • Pancreatic insufficient or pancreatic sufficient
  • No change in insulin status (either initiating or discontinuing) in the past 3 months

Exclusion Criteria:

  • CF liver disease with portal hypertension
  • Systemic glucocorticoid exposure the past 2 weeks (does not include inhaled)
  • Current pulmonary exacerbation treated with antibiotics
  • Baseline or current FEV1 <30% at time of recruitment
  • Transplant recipient
  • Pancreatic sufficient on insulin
  • Started CFTR modulator in the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cystic Fibrosis, Pancreatic Sufficient
CF patients with exocrine pancreatic sufficiency
Device: Frequently Sampled Oral Glucose Tolerance Test and CGM
Patients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor. Using as a tool to collect data.
Radiation: MRI Pancreas and Liver
Patients will undergo an MRI of the pancreas and liver
Cystic Fibrosis, Pancreatic Insufficient, No Insulin
CF patients with exocrine pancreatic insufficiency but not treated with insulin therapy
Device: Frequently Sampled Oral Glucose Tolerance Test and CGM
Patients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor. Using as a tool to collect data.
Radiation: MRI Pancreas and Liver
Patients will undergo an MRI of the pancreas and liver
Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin
CF patients with exocrine pancreatic insufficiency who are treated with insulin therapy for CFRD
Device: Frequently Sampled Oral Glucose Tolerance Test and CGM
Patients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor. Using as a tool to collect data.
Radiation: MRI Pancreas and Liver
Patients will undergo an MRI of the pancreas and liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic agreement between plasma glucose and CGM
Time Frame: 0 min-120min
Difference between blood glucose and CGM result will be calculated for each time point (0min, 30min, 60min, 90min, 120min).
0 min-120min
Pancreatic Fat and Glycemic measures
Time Frame: 0min-120min
Correlation between the degree of pancreatic fat replacement (Class 1-4 and fat fraction) and measures of beta cell function on glucose tolerance testing
0min-120min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM results in CFRD vs. CFND
Time Frame: 0 min-120min
Comparison of CGM parameters (time and excursions >140mg/dL and >200mg/dL between patients with insulin treated CFRD and no insulin treated CFRD
0 min-120min
Pancreatic Fat by Modulator Status
Time Frame: 0min-120min
Comparison of pancreatic fat (Ferrozzi category and fat fraction) in patients who are and are not receiving a CFTR modulator.
0min-120min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Katherine Kutney, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

August 30, 2021

Study Completion (ACTUAL)

August 30, 2021

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (ACTUAL)

May 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Frequently Sampled Oral Glucose Tolerance Test and CGM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe