|
ISRCTN
|
ISRCTN85191494
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Impact of smoking cessation on skeletal muscle
|
|
Scientific title
|
Impact of smoking cessation on skeletal muscle atrophy and hypertrophy pathways in chronic obstructive pulmonary disease (COPD)
|
|
Acronym
|
N/A
|
|
Serial number at source
|
8238
|
|
Study hypothesis
|
Our hypothesis is that smoking cessation in patients with chronic obstructive pulmonary disease (COPD) will lead to an increase in skeletal muscle bulk and endurance and that this will be associated with alterations in the pathways controlling skeletal muscle atrophy and hypertrophy including the Akt/FOXO/atrogene, mTOR and MyoD and myostatin pathways. We also propose that smoking cessation will lead to a more oxidative fibre type with an increase in the expression of type I myosin and reduction in the expression of type II myosin heavy chains. We will investigate this by making detailed assessment of skeletal muscle function and examining biopsies from the quadriceps muscle before and after smoking cessation.
In parallel with this we will study the effect of smoking cessation on lung function, exercise capacity and systemic inflammation.
|
|
Lay summary
|
|
|
Ethics approval
|
UCLH Committee Alpha approved (ref: 09/H0715/37)
|
|
Study design
|
Single centre observational non-randomised diagnosis and screening cohort study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
|
|
Participants - inclusion criteria
|
1. Consenting adult smokers who wish to quit
2. Both COPD patients who smoke and smokers with normal lung function
3. Male and female, lower age limit of 18 years
|
|
Participants - exclusion criteria
|
The presence of significant co-morbidity judged likely to have a significant impact on muscle strength
|
|
Anticipated start date
|
01/11/2009
|
|
Anticipated end date
|
15/08/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
Planned sample size: 95; UK sample size: 95
|
|
Interventions
|
Smoking cessation advice, counselling and pharmacotherapy as clinically indicated. This may include NRT and varenicline. Outcomes will be assessed 8 weeks after the quit date.
|
|
Primary outcome measure(s)
|
Activity of the IGF-1 PI3K/Akt/FOXO/atrogene pathway and the mTOR pathway in muscle biopsy specimens, measured at 8 weeks after quit date
|
|
Secondary outcome measure(s)
|
Measured at 8 weeks after quit date:
1. Dynamic hyperinflation during cycle ergometry
2. MyoD and myostatin protein and mRNA levels
3. Quadriceps endurance
4. Quadriceps strength
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Nick
Hopkinson
|
|
Address
|
Royal Brompton Hospital
Fulham Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW3 6NP
|
|
Country
|
United Kingdom
|
|
Email
|
n.hopkinson@imperial.ac.uk
|
|
Sponsor
|
Imperial College London (UK)
|
|
Address
|
Imperial College
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW7 2AZ
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www3.imperial.ac.uk/
|
|
Date applied
|
14/07/2010
|
|
Last edited
|
15/07/2010
|
|
Date ISRCTN assigned
|
14/07/2010
|
