NCT05229640

Brief Summary

This study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

December 21, 2021

Last Update Submit

July 12, 2023

Conditions

CF - Cystic FibrosisCystic Fibrosis-related DiabetesCystic Fibrosis Liver Disease

Outcome Measures

Primary Outcomes (5)

  • Assess Phenotype of CFLD

    Assess phenotype of CFLD via a Fibroscan performed after a \>3 hour fast

    Visit 1, Day 1

  • Assess Value of Complete Blood Count of CFLD

    Assess phenotype of CFLD via a complete blood count (CBC)

    Visit 1, Day 1

  • Assess Hepatic Function of CFLD

    Assess phenotype of CFLD via a hepatic function test

    Visit 1, Day 1

  • Assess Oral Glucose of CFLD

    Assess phenotype of CFLD via an oral glucose tolerance test

    Visit 1, Day 1

  • Assess CFLD via abdominal imaging

    Assess phenotype of CFLD via abdominal imaging (CT abdomen, Ultrasound, or MRI). If the subject has had a CT of the abdomen, Ultrasound or MRI of the abdomen as part of their standard care, the data will be collected. These procedures will not be performed as part of this study.

    Visit 1, Day 1

Study Arms (1)

Fibroscan

OTHER

One study visit for fibroscan measurement of the liver.

Device: Fibroscan

Interventions

FibroscanDEVICE

Subjects will fast for at least three hours, then have at least 10 fibroscan readings of their liver.

Fibroscan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥ 18 with CF and one of the following:
  • Normal OGTT
  • Elevated OGTT
  • Known CFRD

You may not qualify if:

  • Men and women without CF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (5)

  • Kayani K, Mohammed R, Mohiaddin H. Cystic Fibrosis-Related Diabetes. Front Endocrinol (Lausanne). 2018 Feb 20;9:20. doi: 10.3389/fendo.2018.00020. eCollection 2018.

    PMID: 29515516RESULT

  • Toledano MB, Mukherjee SK, Howell J, Westaby D, Khan SA, Bilton D, Simmonds NJ. The emerging burden of liver disease in cystic fibrosis patients: A UK nationwide study. PLoS One. 2019 Apr 4;14(4):e0212779. doi: 10.1371/journal.pone.0212779. eCollection 2019.

    PMID: 30947265RESULT

  • Colomba J, Netedu SR, Lehoux-Dubois C, Coriati A, Boudreau V, Tremblay F, Cusi K, Rabasa-Lhoret R, Leey JA. Hepatic enzyme ALT as a marker of glucose abnormality in men with cystic fibrosis. PLoS One. 2019 Jul 18;14(7):e0219855. doi: 10.1371/journal.pone.0219855. eCollection 2019.

    PMID: 31318914RESULT

  • Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul;24(7):908-922. doi: 10.1038/s41591-018-0104-9. Epub 2018 Jul 2.

    PMID: 29967350RESULT

  • Hui JM, Sud A, Farrell GC, Bandara P, Byth K, Kench JG, McCaughan GW, George J. Insulin resistance is associated with chronic hepatitis C virus infection and fibrosis progression [corrected]. Gastroenterology. 2003 Dec;125(6):1695-704. doi: 10.1053/j.gastro.2003.08.032.

    PMID: 14724822RESULT

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 Officials

  • Mary C. Drinane, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Staff Physician, Gastroenterology & Hepatology

Study Record Dates

First Submitted

December 21, 2021

First Posted

February 8, 2022

Study Start

March 31, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers.

Locations

US(1)