Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis

NCT03961516 | Completed FDA Device

• 1 other identifier: 20181150
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes; Cystic Fibrosis Liver Disease; Pancreatic Steatosis; Hepatic Steatosis

Keywords

continuous glucose monitor; cystic fibrosis; cystic fibrosis related diabetes

Outcome Measures

Primary Outcomes (2)

• Glycemic agreement between plasma glucose and CGM

  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

  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 Outcomes (2)

• CGM results in CFRD vs. CFND

  0 min-120min

• Pancreatic Fat by Modulator Status

  0min-120min

Study Arms (3)

Cystic Fibrosis, Pancreatic Sufficient

CF patients with exocrine pancreatic sufficiency

Device: Frequently Sampled Oral Glucose Tolerance Test and CGM; Radiation: MRI 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; Radiation: MRI 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; Radiation: MRI Pancreas and Liver

Interventions

Frequently Sampled Oral Glucose Tolerance Test and CGM DEVICE

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.

Cystic Fibrosis, Pancreatic Insufficient, No Insulin; Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin; Cystic Fibrosis, Pancreatic Sufficient

MRI Pancreas and Liver RADIATION

Patients will undergo an MRI of the pancreas and liver

Cystic Fibrosis, Pancreatic Insufficient, No Insulin; Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin; Cystic Fibrosis, Pancreatic Sufficient

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (15)

• Moran A, Dunitz J, Nathan B, Saeed A, Holme B, Thomas W. Cystic fibrosis-related diabetes: current trends in prevalence, incidence, and mortality. Diabetes Care. 2009 Sep;32(9):1626-31. doi: 10.2337/dc09-0586. Epub 2009 Jun 19.

  PMID: 19542209 BACKGROUND

• Adler AI, Shine BS, Chamnan P, Haworth CS, Bilton D. Genetic determinants and epidemiology of cystic fibrosis-related diabetes: results from a British cohort of children and adults. Diabetes Care. 2008 Sep;31(9):1789-94. doi: 10.2337/dc08-0466. Epub 2008 Jun 5.

  PMID: 18535191 BACKGROUND

• Annual Data Report 2016 Cystic Fibrosis Foundation Patient Registry [Internet]. Cystic Fibrosis Foundation Patient Registry. 2016

  BACKGROUND

• Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? J Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.

  PMID: 27977404 BACKGROUND

• Walshaw M. Routine OGTT screening for CFRD - no thanks. J R Soc Med. 2009 Jul;102 Suppl 1(Suppl 1):40-4. doi: 10.1258/jrsm.2009.s19009. No abstract available.

  PMID: 19605874 BACKGROUND

• Li A, Vigers T, Pyle L, Zemanick E, Nadeau K, Sagel SD, Chan CL. Continuous glucose monitoring in youth with cystic fibrosis treated with lumacaftor-ivacaftor. J Cyst Fibros. 2019 Jan;18(1):144-149. doi: 10.1016/j.jcf.2018.07.010. Epub 2018 Aug 10.

  PMID: 30104123 BACKGROUND

• Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.

  PMID: 24359972 BACKGROUND

• Franzese A, Valerio G, Buono P, Spagnuolo MI, Sepe A, Mozzillo E, De Simone I, Raia V. Continuous glucose monitoring system in the screening of early glucose derangements in children and adolescents with cystic fibrosis. J Pediatr Endocrinol Metab. 2008 Feb;21(2):109-16. doi: 10.1515/jpem.2008.21.2.109.

  PMID: 18422023 BACKGROUND

• O'Riordan SM, Hindmarsh P, Hill NR, Matthews DR, George S, Greally P, Canny G, Slattery D, Murphy N, Roche E, Costigan C, Hoey H. Validation of continuous glucose monitoring in children and adolescents with cystic fibrosis: a prospective cohort study. Diabetes Care. 2009 Jun;32(6):1020-2. doi: 10.2337/dc08-1925. Epub 2009 Mar 11.

  PMID: 19279304 BACKGROUND

• Jefferies C, Solomon M, Perlman K, Sweezey N, Daneman D. Continuous glucose monitoring in adolescents with cystic fibrosis. J Pediatr. 2005 Sep;147(3):396-8. doi: 10.1016/j.jpeds.2005.05.004.

  PMID: 16182684 BACKGROUND

• Della Corte C, Mosca A, Majo F, Lucidi V, Panera N, Giglioni E, Monti L, Stronati L, Alisi A, Nobili V. Nonalcoholic fatty pancreas disease and Nonalcoholic fatty liver disease: more than ectopic fat. Clin Endocrinol (Oxf). 2015 Nov;83(5):656-62. doi: 10.1111/cen.12862. Epub 2015 Aug 12.

  PMID: 26201937 BACKGROUND

• Engjom T, Kavaliauskiene G, Tjora E, Erchinger F, Wathle G, Laerum BN, Njolstad PR, Frokjaer JB, Gilja OH, Dimcevski G, Haldorsen IS. Sonographic pancreas echogenicity in cystic fibrosis compared to exocrine pancreatic function and pancreas fat content at Dixon-MRI. PLoS One. 2018 Jul 26;13(7):e0201019. doi: 10.1371/journal.pone.0201019. eCollection 2018.

  PMID: 30048483 BACKGROUND

• Ferrozzi F, Bova D, Campodonico F, De Chiara F, Uccelli M, Bacchini E, Grinzcich R, de Angelis GL, Battistini A. Cystic fibrosis: MR assessment of pancreatic damage. Radiology. 1996 Mar;198(3):875-9. doi: 10.1148/radiology.198.3.8628886.

  PMID: 8628886 BACKGROUND

• Lindblad A, Glaumann H, Strandvik B. Natural history of liver disease in cystic fibrosis. Hepatology. 1999 Nov;30(5):1151-8. doi: 10.1002/hep.510300527.

  PMID: 10534335 BACKGROUND

• Ayoub F, Trillo-Alvarez C, Morelli G, Lascano J. Risk factors for hepatic steatosis in adults with cystic fibrosis: Similarities to non-alcoholic fatty liver disease. World J Hepatol. 2018 Jan 27;10(1):34-40. doi: 10.4254/wjh.v10.i1.34.

  PMID: 29399276 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Fatty Liver

Interventions

Continuous Glucose Monitoring; Liver Extracts

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Tissue Extracts; Complex Mixtures

Study Officials

• Katherine Kutney, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Endocrinology

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 23, 2019
• Study Start: May 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)