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Trial record 8 of 9 for:    Recruiting, Not yet recruiting, Available Studies | Adenosine triphosphate

Magnetic Resonance & Optical Spectroscopy Validation

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ClinicalTrials.gov Identifier: NCT01827527
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

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.

Condition or disease
Validation Studies Magnetic Resonance Spectroscopy

Detailed Description:

Primary Study Objective:

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


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications
Study Start Date : March 2013
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Group/Cohort
Healthy Adult
This is a protocol development study, with no interventions or treatments.



Primary Outcome Measures :
  1. Rate of phosphocreatine (PCr) decay [ Time Frame: Hour 2 ]

    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.


  2. Rate of oxygen uptake [ Time Frame: Hour 2 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adult volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827527


Contacts
Contact: Recruitment Department (407) 303-7100 tri@flhosp.org

Locations
United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    tri@flhosp.org   
Principal Investigator: Heather Cornnell, PhD         
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
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

Additional Information:
Publications:

Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT01827527     History of Changes
Other Study ID Numbers: TRIMDFH 422234
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Adenosine Triphosphate
Validation
Magnetic Resonance Spectroscopy
Optical Spectroscopy