Cystic Fibrosis and Cognitive Function

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT03820349
• Lead Sponsor: University of Minnesota

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-26
• Study Start: 2018-05-07
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

patients with Cystic fibrosis

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI outcome	baseline	Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls

Secondary Outcome Measures

Name	Time	Method
Cognitive function	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.

Trial Locations

Locations (1)

Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States