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Cystic Fibrosis and Cognitive Function

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ClinicalTrials.gov Identifier: NCT03820349
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function

Condition or disease
Cystic Fibrosis

Detailed Description:

A growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is associated with alterations in brain structure and cognitive impairment. People with cystic fibrosis related diabetes (CRFD) are exposed to hyperglycemia as seen in other forms of diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. Both hyperglycemia and chronic inflammation have been postulated to affect brain structure and function. Cystic fibrosis trans-membrane conductance regulator (CFTR). protein is widely expressed in the neurons of the brain including in the hippocampus The hippocampus plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of metabolic stressors. The expression of CFTR in neurons has several potential implications for central nervous system function, including cognition.

The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Cystic Fibrosis and Cystic Fibrosis Related Diabetes on Brain Structure and Cognitive Function
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort
Cystic Fibrosis
Subjects with cystic fibrosis
controls
matched healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. MRI outcome [ Time Frame: baseline ]
    Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: baseline ]
    Compare performance on neurocognitive function testing in subjects with cystic fibrosis and healthy controls. Multiple cognitive domains will be examined including intellectual function, processing speed. attention and memory.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Cystic Fibrosis
Criteria

Inclusion Criteria:

patients with Cystic fibrosis

Exclusion Criteria:

  • History of stroke
  • History of epilepsy
  • History of neurosurgical procedures
  • Past or current history of severe psychiatric illness
  • Pass or current history of alcohol or substance abuse
  • Presence of metallic substances in body or inability to remove before imaging procedure
  • History of claustrophobia or known inability to tolerate MRI
  • Current pregnancy
  • Inability to consent
Contacts and Locations
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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): NCT03820349


Contacts
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Contact: Amir Moheet 6126243209 mohee002@umn.edu

Locations
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United States, Minnesota
Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amir Moheet, MD    612-624-3209    mohee002@umn.edu   
Principal Investigator: Amir Moheet, MD         
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03820349    
Other Study ID Numbers: MED-2018-26438
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
CFRD
Cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases