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Atrophy, MuscularPhase 1NCT01476072

31P MRS Ischaemic Exercise Optimisation and COPD

A Phase 1 study testing MRI scan in people with Atrophy, Muscular, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to obtain a consistent standard of measurement of muscle metabolism while maintaining an acceptable level of subject comfort and use optimised method to measure and compare metabolism in the biceps and quadriceps of patients with… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Atrophy, Muscular
What is being tested?
MRI scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2010to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Fit to safely tolerate procedures
  • Male or female between 18 and 80 years of age
  • If pre-menopausal female, non-pregnant on dipstick urinalysis
  • Subject and responsible physician agree that the subject will be able to comfortably lie in scanning position in the scanner for up to 90 minutes
  • Capable of giving written informed consent
  • All four limbs are intact and free of disease
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  • The following criteria apply to patients with COPD myopathy only:
  • Established diagnosis of COPD with a disease classification of GOLD Stage II and above with suspected or established diagnosis of myopathy and/or COPD with low BMI (under 20 for men and under 19 for women) and/or MVC under 120% of the BMI.
  • At least a 20 pack year history of smoking
  • Resting oxygen saturation above 85% on room air
  • Ambulant and not oxygen-dependent at rest or during mild exertion

Who cannot join

  • Ineligible for MRI/MRS scanning in accordance to local MR safety regulations
  • Any medical condition, acute or chronic, that will lead to potential discomfort when lying supine in the magnet for periods up to 90 min
  • Any medical condition that will lead to potential discomfort with repetitive movement of the limb being tested in the scanner
  • Subjects undergoing ischaemic/anaerobic 31P MRS must have no history of clinically significant peripheral vascular disease, abnormal blood clotting, deep vein thrombosis or pulmonary embolism or suspected clinically significant signs of limb vascular disease on screening examination.
  • Subjects undergoing ischaemic/anaerobic 31P MRS must not have taken the oral contraceptive pill, hormone replacement therapy, or undergone anaesthesia within past 1 month, or have a history of recent prolonged immobility greater than 4 hours (e.g. air travel), or considered unfit in the opinion of the study physician
  • Concurrent medical conditions known or suspected that in the opinion of the responsible physician could confound interpretation of results.
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  • A medical or psychiatric history that in the opinion of the responsible physician would risk safety of the subject or well-being of the subject.
  • The following criteria apply to control subjects and COPD patients participating in Part C of the study:
  • Oxygen saturations below 85% on room air at rest, or significant desaturation on mild exertion.
  • Current or recent (<4 weeks) infectious exacerbation of COPD requiring corticosteroid therapy at the time of screening or scanning visit day.
  • Any significant medical illness other than COPD which, in the opinion of the study physician, may preclude participation or which by virtue of being associated with muscle weakness may cause distortion of the results (e.g. neuromuscular disease, severe heart failure \&c).
  • Control subjects with any history of regular smoking

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    London, London, W12 ONN

Other trials in United Kingdom

About this study

Official title: 31P MRS Ischaemic Exercise Optimisation and COPD Myopathy Study

An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to obtain a consistent standard of measurement of muscle metabolism while maintaining an acceptable level of subject comfort and use optimised method to measure and compare metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control subjects

Read the detailed description

31P Magnetic Resonance Spectroscopy (31P MRS) is a non-invasive method to measure muscle metabolism during exercise. This protocol is intended to provide information for planning future clinical trials applying 31P MRS as an endpoint measure for proof of pharmacology studies with novel therapeutic molecules. Parts A \& B of this study will refine imaging and exercise protocols for 31P MRS during brief periods of muscle ischaemia and will assess the test-retest variance. In Part C we will apply 31P MRS with aerobic exercise in a pilot study to estimate differences in skeletal muscle oxidative metabolism between age- and sex-matched control subjects and patients with myopathy associated with Chronic Obstructive Pulmonary Disease.

Being tested
MRI scan
Medical subject headings
Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI scanOther

    MRI scan only, methodology study with no other intervention

Study groups in NCT01476072
Study groupRoleWhat they receive
no treatmentNo interventionMRI scans only
Receives: Other: MRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. level of skeletal muscle metabolism

    ADP, ATP, PCr, Pi, and pH will be measured during rest, anaerobic exercise and recovery to determine muscle metabolism.

    Measured: 1 year

Secondary outcomes (1)

  1. determine Markers of disease in patients with COPD-related myopathy

    tests such as spirometry, muscle biopsy, muscle cross-sectional area CSA, muscle strength to indicate level of disease progression

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01476072
Sponsor's protocol ID
113784
Status last verified
Jun 2013
First submitted
29 Sep 2011
Last updated
1 Jul 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRI scan in people with Atrophy, Muscular, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

level of skeletal muscle metabolism (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01476072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.

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