Magnetic Resonance & Optical Spectroscopy Validation

Magnetic Resonance Spectroscopy Clinical Trial

Official title:

Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01827527
• Other study ID #: TRIMDFH 422234
• Status: Recruiting
• Start date: March 2013
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: AdventHealth Translational Research Institute
• Contact: Recruitment Department
• Phone: (407) 303-7100
• Email: tri[@]flhosp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Primary Study Objective:

To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet in conjunction with Optical Spectroscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Magnetic Resonance Spectroscopy
• Validation Studies

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Blei 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. Erratum In: J Physiol (Lond) 1994 Mar 15;475(3):548. — View Citation

Blei 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. — View Citation

Buchli 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. — View Citation

Conley 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. — View Citation

Johannsen 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. — View Citation

Jubrias 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. — View Citation

Jubrias 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. — View Citation

Kemper 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. — View Citation

Larson-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. — View Citation

Larson-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. — View Citation

Larson-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. — View Citation

Lebon 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. — View Citation

Marcinek 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. — View Citation

Newcomer 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Translational Research Institute for Metabolism and Diabetes