Clinical Trial: A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study in Healthy Male Volunteers to Evaluate a Skeletal-Muscle Microbiopsy Technique for Suitability of Use With Dynamic Proteomic Measurement

Brief Summary: This is a single-blind, randomized placebo-controlled, parallel study, where the study volunteers will be blinded to testosterone/placebo treatment. This study will test a relatively new, less invasive method for collecting muscle tissue to determine if this method is appropriate for collecting muscle samples for the assessment of the fractional synthetic rates (FSR) of muscle-derived proteins. This study will also investigate whether the FSR of proteins may serve as early biomarkers for muscle anabolism, a known anabolic agent (testosterone) will be administered to healthy, elderly male subjects over a 3 week period. The fractional synthetic rate of several muscle-derived proteins will be analyzed at Baseline and during the period of testosterone treatment using deuterium labelling of these proteins by the incorporation of deuterium from deuterated water (D2O).

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change from Baseline in muscle derived protein synthesis rate [ Time Frame: Baseline and Day 21 ]

Muscle protein synthesis will be assessed by measuring the fractional synthetic rate of muscle-derived proteins in both muscle biopsy samples and in blood after subjects have ingested deuterated water. The FSR of several muscle-derived proteins will be analyzed at baseline and during the period of testosterone treatment using deuterium labelling of these proteins by the incorporation of deuterium from D2O.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in lower extremity strength using the 1-repetition maximum (1-RM) leg strength, FSRs from muscle proteins derived from muscle biopsies and serum samples [ Time Frame: Baseline, Day 7, 14, and 21 ]
    Lower extremity strength will be measured as the 1-RM on a leg press device. Strength will be measured at baseline (Day 1, prior to start of testosterone) and at study end (Day 21). The FSR of several muscle-derived proteins will be analyzed at Baseline and during the period in both muscle biopsy samples and in blood after subjects have ingested deuterated water.
  • Changes in FSR in muscle and serum derived muscle proteins [ Time Frame: Baseline, Day 7, 14, and 21 ]
    The FSR of several muscle-derived proteins will be analyzed at Baseline and during the period in both muscle biopsy samples and in blood after subjects have ingested deuterated water.
  • Number of biopsy samples required to obtain desired collection weight [ Time Frame: Baseline, Day 7, 14, and 21 ]
  • Number of participants with biopsy-related adverse events [ Time Frame: Upto Week 7 ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: October 10, 2013
Date Started: May 5, 2014
Date Completion:
Last Updated: May 5, 2017
Last Verified: May 2017