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Completed

NCT Number: NCT03820349

Cystic Fibrosis and Cognitive Function

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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