NCT03820349

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

February 26, 2018

Last Update Submit

June 30, 2021

Conditions

Cystic Fibrosis

Keywords

CFRDCystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • MRI outcome

    Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls

    baseline

Secondary Outcomes (1)

  • Cognitive function

    baseline

Study Arms (2)

Cystic Fibrosis

Subjects with cystic fibrosis

controls

matched healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Cystic Fibrosis

You may qualify if:

  • patients with Cystic fibrosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

January 29, 2019

Study Start

May 7, 2018

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

July 2, 2021

Record last verified: 2021-06

Locations

US(1)