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A CFit Study - Baseline

NCT03234387 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-04-28

No results posted yet for this study

Summary

A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research with the aim to maximise the quality of life (QoL) of the aging CF population. Recent research has demonstrated that the traditional method of determining disease progression, i.e. pulmonary function, no longer adequately predict survival rates. Therefore, various bodies have promoted cardiopulmonary exercise testing (CPET), as outcomes from this test (e.g. one's maximal O2 uptake \[VO₂max\]) are known predictors of the QoL, risk of hospitalisation and prognosis of individuals with CF.

One of the most common non-pulmonary co-morbidities of CF is CF-related diabetes (CFRD). Importantly, CFRD is associated with a poorer pulmonary function compared to CF patients without CFRD, and ultimately a worsened prognosis. Despite this, the influence an impaired glycaemic control has upon the VO₂max derived from a CPET is unknown in CF. Therefore, the present study aims to assess whether VO₂max, an established determinant of QoL, differs between patients with CF with and without established CFRD as well as a group of age- and gender-matched healthy control subjects.

The additional measures within the present study, such as: biomarkers of inflammation, redox balance and nitric oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial function will aid our knowledge of the physiological abnormalities which are a cause or consequence of CFRD. Importantly, by identifying the factors which may contribute to CFRD progression and those that are viable for early intervention, mean the aims and objectives of this study are compatible with the top 10 research objectives set by the CF Trust.

Conditions

  • Cystic Fibrosis (CF)
  • Cystic Fibrosis-related Diabetes

Interventions

OTHER

No intervention - only assessments.

No intervention only a number of assessments. Participants will be assessed during a maximal cardiopulmonary exercise testing on an exercise bike during 1 visit, and before and after an oral glucose tolerance test on a following visit.

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Loughborough University

    collaborator OTHER

  • Queen Alexandra Hospital

    collaborator UNKNOWN

  • University of Portsmouth

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234387 on ClinicalTrials.gov