Friedreich AtaxiaNCT03122925
TCA Cycle in the Dentate in Friedreich's Ataxia
An observational study of Friedreich Ataxia, run by University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Friedreich Ataxia
- What is being tested?
- MR
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 11 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls Friedreich's Ataxia diagnosis
Who may be able to join
- 18 years of age or older
- able to consent for themselves
- considered healthy (controls) OR be diagnosed with FRDA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Friedreich Ataxia
- Being tested
- MR
- Medical subject headings
- Friedreich Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRDevice
MR
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy subjects Receives: Device: MR | |
| Friedreich's Ataxia | Diagnosed for Friedreich's Ataxia Receives: Device: MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCA cycle rate in the dentate nucleus
value between 0 to 2 micromol/g/min
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start29 Aug 2017
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Friedreich AtaxiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Gilles Henry, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122925
- Sponsor's protocol ID
- RAD-2017-25500
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2017
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia
- ClinicalTrials.gov ID
- NCT03122925
- Acronym / sponsor ID
- RAD-2017-25500
- Conditions
- Friedreich Ataxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: MRHealthy subjects |
| Friedreich's Ataxia | – | Device: MRDiagnosed for Friedreich's Ataxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls Friedreich's Ataxia diagnosis
Key inclusion criteria (3 listed)
- 18 years of age or older
- able to consent for themselves
- considered healthy (controls) OR be diagnosed with FRDA.
Key exclusion criteria (8 listed)
- All subjects:
- Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
- Pregnancy
- Clautrophobia
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRMR | Device | Control, Friedreich's Ataxia |
Primary outcome
TCA cycle rate in the dentate nucleus
Time frame: Baseline
value between 0 to 2 micromol/g/min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Gilles Henry, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Friedreich Ataxia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCA cycle rate in the dentate nucleus (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.