31P MRS Ischaemic Exercise Optimisation and COPD

NCT01476072 | Completed Phase 1

• 1 other identifier: 113784
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 COPD-related myopathy and control subjects

Conditions

Atrophy, Muscular

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (1)

• determine Markers of disease in patients with COPD-related myopathy

  1 year

Study Arms (1)

no treatment

NO INTERVENTION

MRI scans only

Other: MRI scan

Interventions

MRI scan OTHER

MRI scan only, methodology study with no other intervention

no treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, London, W12 ONN, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: November 22, 2011
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

GB (1)