Cystic Fibrosis Clinical Trial
Official title:
A CFit Study: To What Extent Does a Single Session of Exercise Training Influence Measures of Inflammation, Oxidative Stress, Nitric Oxide Bioavailability, Microvascular Endothelial Function and Dysglycaemia in Patients With Cystic Fibrosis?
NCT number | NCT03237767 |
Other study ID # | ZS003 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | December 1, 2020 |
Verified date | April 2021 |
Source | University of Portsmouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 aiming to maximise the quality of life (QoL) of the aging CF population. Over recent decades, exercise training has become an integral part of CF management by improving ones aerobic exercise function and QoL. However, the effects exercise training has upon other aspects of the disease, e.g. metabolic and vascular abnormalities, remains largely unknown. The increased survival age associated with CF means the non-pulmonary co-morbidities are becoming increasingly prevalent and clinically important. For example, CF-related diabetes (CFRD) is one of the most common non-pulmonary co-morbidities of CF, and is associated with patients having a poorer pulmonary function and nutritional state, which ultimately leads to a worsened prognosis. Despite the efficacy of exercise training to manage dysglycaemia in other populations (e.g. type 2 diabetes mellitus only a single study has investigated its efficacy in patients with CF, whereby authors reported various encouraging findings (e.g. an improved OGTT score and insulin sensitivity). The present study aims to build on previous trials by comparing the therapeutic effects of a single session of high-intensity interval exercise (HIIE) and moderate intensity exercise (MIE) upon the 24 hour, ambulatory glycaemic profile of patients with CF. Additionally, the present study will identify whether HIIE and/or MIE can mediate the consequences of transient hyperglycaemia when considering: biomarkers of inflammation, oxidative stress and nitric oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial function. The present study supports the top 10 research priorities set by the CF Trust, by further investigating the potential for exercise training to prevent/manage multiple aspects of CF, including dysglycaemia.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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) and, where possible, diagnostic genotyping - 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 Criteria: - 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 Exclusion during testing: - Onset of acute infection - Becomes and/or is tested to be pregnant following enrolment to the study - Experiences significant hypoxaemia during visit 2 of the CFit_BL protocol (IRAS ID: 225310) which requires supplemental O2. Under these circumstances, participants will be invited to continue their participation under the CFit_BL trial (IRAS ID: 225310) - Unable to understand or cooperate with study protocol - The individual does not wish to participate further |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Sport and Exercise Science | Portsmouth | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Portsmouth | Loughborough University, Queen Alexandra Hospital, Portsmouth, University Hospital Southampton NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose concentration before and after oral glucose tolerance test | Glucose concentration before and after oral glucose tolerance test (which follows an exercise training session) | Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion) | |
Primary | Insulin concentration before and after oral glucose tolerance tolerance | Insulin concentration before and after oral glucose tolerance test (which follows an exercise training session) | Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion) | |
Primary | Glycaemic control (measured using arm-mounted Freestyle Libre continuous glucose monitor) | Glycaemic control fixed to the arm will measure glucose excursions continuously | Continuous measurement through study completion (2 week period) | |
Secondary | Nitrotyrosine (NT) | Nitrotyrosine (NT) measured from plasma | Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: NT measured immediately before glucose ingestion and 120 minutes after | |
Secondary | Total cysteine (tCys) | Total cysteine (tCys) measured from plasma | Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tCys measured immediately before glucose ingestion and 120 minutes after | |
Secondary | Total glutathione (tGSH) | Total glutathione (tGSH) measured from plasma | Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tGSH measured immediately before glucose ingestion and 120 minutes after | |
Secondary | Tumor necrosis factor alpha (TNF-alpha) | Tumor necrosis factor alpha (TNF-alpha) measured from plasma | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: TNF-alpha measured immediately before glucose ingestion and 60, 120 and 180 minutes after) | |
Secondary | Soluble vascular cell adhesion molecule (sVCAM-1) | Soluble vascular cell adhesion molecule-1 (sVCAM-1) measured from plasma | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: sVCAM-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after) | |
Secondary | Endothelin-1 (ET-1) | Endothelin-1 (ET-1) | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: ET-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after) | |
Secondary | Interleukin-6 (IL-6) | Interleukin-6 (IL-6) | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: IL-6 measured immediately before glucose ingestion and 60, 120 and 180 minutes after) | |
Secondary | [Nitrite] ([NO2]) | [Nitrite] ([NO2])measured from plasma | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: NO2 measured immediately before glucose ingestion and 60, 120 and 180 minutes after) | |
Secondary | Pulmonary function (forced expiratory volume in 1 second, forced vital capacity, peaf expiratory flow and mid-forced expiratory flow) measured using flow-volume loop spirometry | Pulmonary function will be measured using flow-volume spirometry and presented in both absolute units and as a percentage of predictive normative reference values | Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: pulmonary function measured immediately before glucose ingestion | |
Secondary | Insulin iontophoresis | Insulin iontophoresis measures of microvascular endothelial function | Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: insulin iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after. | |
Secondary | Acetylcholine iontophoresis | Acetylcholine iontophoresis measures of microvascular endothelial function | Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: acetylcholine iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after. | |
Secondary | Dietary intake | Dietary intake measured using MyFitness Pal application and dietary records | Continuous measurement through study completion (2 weeks), participants will record everything that they eat and drink | |
Secondary | Physical activity | Physical activity measured using wrist worn accelerometer (GeneActiv) | Continuous measurement through study completion (2 week period) |
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