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Protocol Summary for 113784

Protocol Summary
Protocol Id: 113784
Secondary Ids:
Title: 31P MRS Ischaemic Exercise Optimisation and COPD Myopathy Study
Phase: phase 1
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • United Kingdom: Research Ethics Committee
Collaborators:
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
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.
Record Verification Date: September 2011
Status: Completed
Why Study Stopped:
Study Start Date: April 2010
Study Completion Date: August 2011
Study Completion Date Type: Actual
Primary Completion Date: August 2011
Primary Completion Date Type: Actual
Study Design: Case-Control
Time Perspective: Prospective
Biospecimen Retention: None retained
Biospecimen Description:
Primary Outcomes:
  • level of skeletal muscle metabolism 1 year
Secondary Outcomes:
  • determine Markers of disease in patients with COPD-related myopathy 1 year
Conditions:
  • Atrophy, Muscular
Keywords:
Study Population: In part A subjects will be recruited until numbers are sufficient to meet the objectives of Part A, up to a maximum of 25 subjects. Up to 15 subjects will be studied in part B. Up to 25 subjects with COPD and 25 control subjects will be enrolled to allow at least 12 patients and 12 age- and sex- matched controls to be studied in part C.
Sampling Method: Non probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 80 Year
Enrollment: 75
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information