- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03122925
TCA Cycle in the Dentate in Friedreich's Ataxia
Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia
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.
Study Overview
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- CMRR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- able to consent for themselves
- considered healthy (controls) OR be diagnosed with FRDA.
Exclusion Criteria:
- All subjects:
- Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
- Pregnancy
- Clautrophobia
- Diabetes
- Clinically significant cardiac disease
Control subjects:
- Neurological disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Healthy subjects
|
MR
|
Friedreich's Ataxia
Diagnosed for Friedreich's Ataxia
|
MR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TCA cycle rate in the dentate nucleus
Time Frame: Baseline
|
value between 0 to 2 micromol/g/min
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre-Gilles Henry, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Mitochondrial Diseases
- Cerebellar Diseases
- Spinocerebellar Degenerations
- Ataxia
- Cerebellar Ataxia
- Friedreich Ataxia
Other Study ID Numbers
- RAD-2017-25500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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