Status:
TERMINATED
A CFit Study - Baseline
Lead Sponsor:
University of Portsmouth
Collaborating Sponsors:
University Hospital Southampton NHS Foundation Trust
Loughborough University
Conditions:
Cystic Fibrosis (CF)
Cystic Fibrosis-related Diabetes
Eligibility:
All Genders
12+ years
Brief 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 ...
Detailed Description
Participants and recruitment The present study will be a pilot, cross-sectional trial in individuals with CFRD (n = 15), as well as age- and gender-matched CF controls without diabetes (n = 15) and ag...
Eligibility Criteria
Inclusion
- GROUP 1:
- Cystic fibrosis (CF) with established CF-related diabetes:
- Males and females ≥ 12 years of age
- CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride \> 60 mmol·L-1 \> 100 mg sweat) and, where possible, diagnostic genotyping
- Established CFRD in accordance with the most recent American Diabetes Association positional statement. This statement recommends CFRD is diagnosed using a 2 hour OGTT. However, the present study will also include those based on fasting plasma glucose and glycated hemoglobin levels, when symptoms of diabetes are also present:
- 2 hour OGTT plasma glucose ≥ 200 mg.dL-1 (11.1 mmol.L-1)
- Fasting plasma glucose ≥ 126 mg.dL-1 (7.0 mmol.L-1)
- Glycated hemoglobin ≥ 48 mmol/mol
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
- No increase in symptoms or weight loss in the preceding 2 weeks
Exclusion
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
- Unstable co-morbid asthma (daily pulmonary function variability of \>20%)
- Is pregnant during the initial screening process
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not of a suitable age for testing
- GROUP 2:
- Cystic fibrosis (CF) without established CF-related diabetes:
- Inclusion Criteria:
- Males and females ≥ 12 years of age
- CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride \> 60 mmol·L-1 \> 100 mg sweat), where possible, diagnostic genotyping would also be desired
- No evidence of established, gestational or exacerbation induced CFRD in accordance with the American Diabetes Association criteria (stated above).
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
- No increase in symptoms or weight loss in the preceding 2 weeks
Key Trial Info
Start Date :
November 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03234387
Start Date
November 17 2017
End Date
December 1 2020
Last Update
April 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Sport and Exercise Science
Portsmouth, Hampshire, United Kingdom, PO1 2ER