CompletedPhase 1

Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)

United States14 participantsStarted 2012-01

Plain-language summary

The purpose of this trial is to determine if an alternative energy source will impact brain metabolism in a disorder characterized by glucose metabolism failure in the brain. The central hypothesis tested in this investigation is whether circumventing impaired glucose metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC) through alternative metabolic pathways.

Who can participate

Age range1 Month – 20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female * Ages 1 month to \<21 years of age * Diagnosed with glucose transporter type I deficiency. * Age matched (within 1 year) controls not diagnosed with G1D. Exclusion Criteria: * All subjects carrying body metal implants incompatible with the exposure to a magnetic field * Subjects unable to tolerate the MRI and MRS procedures due to anxiety * Subjects receiving oxygen supplementation or those confined to a bed or stretcher * Subjects currently receiving a ketogenic diet, due to a high risk of seizure recurrence while transitioning off ketosis. * Patients behaviorally unable to hold still for imaging procedures (rather than limited by seizure activity) will be excluded.

What they're measuring

Number of Participants With Reduction in Spike-wave Fraction of the EEG Recording Time

Timeframe: 1 day

Trial details

NCT IDNCT02018315

SponsorJuan Pascual

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

Results submitted2019-02-12

View on ClinicalTrials.gov More Glucose Transporter Type 1 Deficiency Syndrome trials