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

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ClinicalTrials.gov Identifier: NCT03961516
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Kutney, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Cystic Fibrosis-related Diabetes Cystic Fibrosis Liver Disease Pancreatic Steatosis Hepatic Steatosis Device: Frequently Sampled Oral Glucose Tolerance Test and CGM Radiation: MRI Pancreas and Liver

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

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

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

Radiation: MRI Pancreas and Liver
Patients will undergo an MRI of the pancreas and liver




Primary Outcome Measures :
  1. Glycemic agreement between plasma glucose and CGM [ Time Frame: baseline ]
    Difference between blood glucose and CGM result will be calculated for each time point.

  2. Pancreatic Fat and Glycemic measures [ Time Frame: baseline ]
    Correlation between the degree of pancreatic fat replacement (Class 1-4 and fat fraction) and measures of beta cell function on glucose tolerance testing


Secondary Outcome Measures :
  1. CGM results in CFRD vs. CFND [ Time Frame: baseline ]
    Comparison of CGM parameters (time and excursions >140mg/dL and >200mg/dL between patients with insulin treated CFRD and no insulin treated CFRD

  2. Pancreatic Fat by Modulator Status [ Time Frame: baseline ]
    Comparison of pancreatic fat (Ferrozzi category and fat fraction) in patients who are and are not receiving a CFTR modulator.



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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961516


Contacts
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Contact: Katherine Kutney, MD 216-844-3661 katherine.kutney@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Katherine Kutney, MD    216-844-3661    katherine.kutney@uhhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Katherine Kutney, MD University Hospitals Cleveland Medical Center
Publications:
Annual Data Report 2016 Cystic Fibrosis Foundation Patient Registry [Internet]. Cystic Fibrosis Foundation Patient Registry. 2016

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Responsible Party: Katherine Kutney, Assistant Professor of Pediatric Endocrinology, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03961516    
Other Study ID Numbers: 20181150
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katherine Kutney, University Hospitals Cleveland Medical Center:
continuous glucose monitor
cystic fibrosis
cystic fibrosis related diabetes
Additional relevant MeSH terms:
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Cystic Fibrosis
Liver Diseases
Fatty Liver
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Gastrointestinal Agents