TCA Cycle in the Dentate in Friedreich's Ataxia
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|ClinicalTrials.gov Identifier: NCT03122925|
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2017
Last Update Posted : April 18, 2019
OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a group of control subjects and subjects with Friedreich's Ataxia (FRDA).
HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label incorporation from glucose to glutamate in the brain using in vivo magnetic resonance spectroscopy.
|Condition or disease||Intervention/treatment|
|Friedreich Ataxia||Device: MR|
The investigators will measure the TCA cycle rate in the dentate nucleus in a group of FRDA patients and in a group of age-matched healthy controls using 13C MRS in vivo together with systemic i.v. infusion of 13C-labeled glucose.
The investigators aim to obtain adequate data in 16 subjects grouped as follows:
- n=4 pilot subjects (healthy subjects) for testing and optimization of the experimental setup.
- n=6 healthy controls
- n=6 FRDA patients
In other to reach this goal, the investigators plan to recruit up to 20 subjects, in case some subjects withdraw before completion of the MR scan, or in case the measured data are not adequate (e.g. technical problem with the scanner).
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Diagnosed for Friedreich's Ataxia
- TCA cycle rate in the dentate nucleus [ Time Frame: Baseline ]value between 0 to 2 micromol/g/min
Biospecimen Retention: Samples Without DNA
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): NCT03122925
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Pierre-Gilles Henry, PhD||University of Minnesota - Clinical and Translational Science Institute|