Cystic Fibrosis and Cognitive Function

Cystic Fibrosis Clinical Trial

Official title:

Effects of Cystic Fibrosis and Cystic Fibrosis Related Diabetes on Brain Structure and Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820349
• Other study ID #: MED-2018-26438
• Status: Completed
• Start date: May 7, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: June 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI outcome	Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls	baseline
Secondary	Cognitive function	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.	baseline