Magnetic Resonance & Optical Spectroscopy Validation
Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications
1 other identifier
observational
31
1 country
1
Brief Summary
The purpose of this study is to develop and refine techniques for using magnetic resonance and optical spectroscopy to investigate how your body uses energy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedApril 17, 2026
April 1, 2026
11.8 years
April 4, 2013
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of phosphocreatine (PCr) decay
The PCr decay (rate of PCr breakdown during ischemia) will be used to measure the ATP turnover rates (ATPase). After the baseline is established, the volunteer will be asked to perform contractions of the quadriceps (by slight kicking) for up to 45 seconds. . After kicking is stopped, the volunteer will remain still for an additional 5 minutes in order to allow the PCr peak to return to baseline. The ATPase experiment will also be performed by acquiring 31P Spectra every 6 seconds.
Hour 2
Rate of oxygen uptake
OS will be used to measure the oxygen (O2) uptake by following the rate of Hb-O2 and Mb-O2 deoxygenation during ischemia. The rate of the depletion of these O2 stores measures the rate of O2 uptake by the mitochondria. The Horbia Jobin Yvon optical system will be used. The OS acquisition procedure has been thoroughly described by Marcinek et.al
Hour 2
Study Arms (1)
Healthy Adult
This is a protocol development study, with no interventions or treatments.
Eligibility Criteria
Healthy adult volunteers
You may qualify if:
- Male or female
- Age 18 - 89
- Healthy (self assessed)
- Weight under 350lbs
- Able to walk 50 yards without stopping
- Able to travel to hospital for study visits
- Able to follow a 3-step command
- Able to remain in magnetic resonance (MR) scanner for up to 2 hours
You may not qualify if:
- Have internal metal medical devices, including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws, metal fragments in your eye, or non-removable jewelry such as rings.
- Are unwilling or unable to complete the imaging procedures for the duration of the magnetic resonance imaging (MRI) scan due to claustrophobia or other reason.
- Serious mental illness that might preclude subject's ability to comply with study treatment
- Are pregnant or plan on becoming pregnant in the next 8 weeks.
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Varicose Veins
- Known genetic factor (Factor V Leiden, etc.) or hypercoagulable state, including cancer, leukemia - such as chronic myelocytic leukemia (CML), hemoglobinopathies - such as sickle-cell disease and multiple myeloma and other proteinopathies.
- Diagnosed peripheral arterial or vascular disease
- Family history of primary DVT or PE
- Peripheral neuropathy
- History of chronic venous stasis or lower extremity edema
- Female taking hormonal birth control (oral or otherwise) AND smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804, United States
Related Publications (15)
Amara CE, Shankland EG, Jubrias SA, Marcinek DJ, Kushmerick MJ, Conley KE. Mild mitochondrial uncoupling impacts cellular aging in human muscles in vivo. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):1057-62. doi: 10.1073/pnas.0610131104. Epub 2007 Jan 10.
PMID: 17215370BACKGROUNDConley KE, Jubrias SA, Amara CE, Marcinek DJ. Mitochondrial dysfunction: impact on exercise performance and cellular aging. Exerc Sport Sci Rev. 2007 Apr;35(2):43-9. doi: 10.1249/JES.0b013e31803e88e9.
PMID: 17417049BACKGROUNDJubrias SA, Esselman PC, Price LB, Cress ME, Conley KE. Large energetic adaptations of elderly muscle to resistance and endurance training. J Appl Physiol (1985). 2001 May;90(5):1663-70. doi: 10.1152/jappl.2001.90.5.1663.
PMID: 11299253BACKGROUNDLarson-Meyer DE, Newcomer BR, Hunter GR, Joanisse DR, Weinsier RL, Bamman MM. Relation between in vivo and in vitro measurements of skeletal muscle oxidative metabolism. Muscle Nerve. 2001 Dec;24(12):1665-76. doi: 10.1002/mus.1202.
PMID: 11745976BACKGROUNDLarson-Meyer DE, Newcomer BR, Hunter GR, Hetherington HP, Weinsier RL. 31P MRS measurement of mitochondrial function in skeletal muscle: reliability, force-level sensitivity and relation to whole body maximal oxygen uptake. NMR Biomed. 2000 Jan;13(1):14-27. doi: 10.1002/(sici)1099-1492(200002)13:13.0.co;2-0.
PMID: 10668050BACKGROUNDBlei ML, Conley KE, Kushmerick MJ. Separate measures of ATP utilization and recovery in human skeletal muscle. J Physiol. 1993 Jun;465:203-22. doi: 10.1113/jphysiol.1993.sp019673.
PMID: 8024651BACKGROUNDLarson-Meyer DE, Newcomer BR, Hunter GR, McLean JE, Hetherington HP, Weinsier RL. Effect of weight reduction, obesity predisposition, and aerobic fitness on skeletal muscle mitochondrial function. Am J Physiol Endocrinol Metab. 2000 Jan;278(1):E153-61. doi: 10.1152/ajpendo.2000.278.1.E153.
PMID: 10644550BACKGROUNDNewcomer BR, Boska MD, Hetherington HP. Non-P(i) buffer capacity and initial phosphocreatine breakdown and resynthesis kinetics of human gastrocnemius/soleus muscle groups using 0.5 s time-resolved (31)P MRS at 4.1 T. NMR Biomed. 1999 Dec;12(8):545-51. doi: 10.1002/(sici)1099-1492(199912)12:83.0.co;2-j.
PMID: 10668047BACKGROUNDLebon V, Dufour S, Petersen KF, Ren J, Jucker BM, Slezak LA, Cline GW, Rothman DL, Shulman GI. Effect of triiodothyronine on mitochondrial energy coupling in human skeletal muscle. J Clin Invest. 2001 Sep;108(5):733-7. doi: 10.1172/JCI11775.
PMID: 11544279BACKGROUNDJohannsen DL, Conley KE, Bajpeyi S, Punyanitya M, Gallagher D, Zhang Z, Covington J, Smith SR, Ravussin E. Ectopic lipid accumulation and reduced glucose tolerance in elderly adults are accompanied by altered skeletal muscle mitochondrial activity. J Clin Endocrinol Metab. 2012 Jan;97(1):242-50. doi: 10.1210/jc.2011-1798. Epub 2011 Nov 2.
PMID: 22049170BACKGROUNDJubrias SA, Crowther GJ, Shankland EG, Gronka RK, Conley KE. Acidosis inhibits oxidative phosphorylation in contracting human skeletal muscle in vivo. J Physiol. 2003 Dec 1;553(Pt 2):589-99. doi: 10.1113/jphysiol.2003.045872. Epub 2003 Sep 26.
PMID: 14514869BACKGROUNDBuchli R, Boesiger P. Comparison of methods for the determination of absolute metabolite concentrations in human muscles by 31P MRS. Magn Reson Med. 1993 Nov;30(5):552-8. doi: 10.1002/mrm.1910300505.
PMID: 8259055BACKGROUNDKemper WF, Lindstedt SL, Hartzler LK, Hicks JW, Conley KE. Shaking up glycolysis: Sustained, high lactate flux during aerobic rattling. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):723-8. doi: 10.1073/pnas.98.2.723. Epub 2000 Dec 19.
PMID: 11120879BACKGROUNDBlei ML, Conley KE, Odderson IB, Esselman PC, Kushmerick MJ. Individual variation in contractile cost and recovery in a human skeletal muscle. Proc Natl Acad Sci U S A. 1993 Aug 1;90(15):7396-400. doi: 10.1073/pnas.90.15.7396.
PMID: 8346262BACKGROUNDMarcinek DJ, Schenkman KA, Ciesielski WA, Conley KE. Mitochondrial coupling in vivo in mouse skeletal muscle. Am J Physiol Cell Physiol. 2004 Feb;286(2):C457-63. doi: 10.1152/ajpcell.00237.2003. Epub 2003 Oct 1.
PMID: 14522819BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Steven R. Smith, MD
Translational Research Institute for Metabolism and Diabetes
- PRINCIPAL INVESTIGATOR
Heather Cornnell, PhD
Translational Research Institute for Metabolism and Diabetes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 9, 2013
Study Start
March 1, 2013
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
April 17, 2026
Record last verified: 2026-04