An Early Phase 1 interventional study of sodiumlactate in GLUT1 Deficiency Syndrome, GLUT1DS1 and GLUT1DS2, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by Radboud University Medical Center · Early Phase 1, Interventional, and Treatment
This study investigates the effect of lactate infusion on epileptic discharges on EEG and seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.
In glucose transporter 1 deficiency syndrome (GLUT1DS) cerebral glucose uptake from the systemic blood circulation is limited, because of deficient transport of glucose across the blood-brain barrier by the transporter protein (GLUT1). Classically patients present with developmental problems, movement disorders and severe epilepsy. There is no curative treatment for GLUT1DS, and anti-epileptic drugs usually have little to no effect. The ketogenic diet, providing ketones as an alternative energy substrate for the brain is an effective treatment option for the epilepsy and movement disorders in many GLUT1DS patients. Unfortunately, not in all GLUT1DS patients the ketogenic diet has a positive effect and other treatment options for these patients are very limited.
Traditionally, lactate is seen as a waste product of glycolysis during anaerobic conditions and a marker of ischemia. Interestingly, research has shown the beneficial side of lactate as an energy source for different organs. It seems that the brain can indeed use lactate as an alternative energy metabolite, besides glucose and ketones. The aim of this study is to investigate whether lactate can be an alternative energy metabolite in the GLUT1DS brain, and reduce epileptic discharges on EEG when intravenously administered in patients with GLUT1DS.
22 studies on the registry are indexed under Glut1 Deficiency Syndrome; 2 are open to participants now.
This study's enrollment of 2 is below the median of 17 across 15 interventional studies indexed under Glut1 Deficiency Syndrome.
Browse Glut1 Deficiency Syndrome studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Clinically significant
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three GLUT1DS patients with drug resistant epilepsy who tried the ketogenic diet without any benefits.
Other: sodiumlactate
intravenous sodiumlactate 600mmol/L
Number of changes in epileptic discharges on EEG during the infusion of lactate.
All subjects have frequent epileptic discharges on EEG. We want to objectify the change in epileptic discharges on EEG during and after the infusion of sodium lactate.
Time frame: 1 day
Change in seizure frequency clinical visible by caregivers during and after infusion of sodium lactate.
All subjects have frequent seizures, we want to see if these clinically visible seizures reduce during or after infusion with sodium lactate.
Time frame: 1 day
Concentration of lactate in blood during and after sodium lactate infusion
Time frame: 1 day
Concentration of glucose in blood during and after sodium lactate infusion
Time frame: 1 day
Concentration of sodium in blood during and after sodium lactate infusion
Time frame: 1 day
Concentration of potassium in blood during and after sodium lactate infusion
Time frame: 1 day
Concentration of bicarbonate in blood during and after sodium lactate infusion
Time frame: 1 day
Concentration of chloride in blood during and after sodium lactate infusion
Time frame: 1 day
pH in blood during and after sodium lactate infusion
Time frame: 1 day
Plan to share: No — We want to include three patients, who all are there own control. If one of their EEGs shows interesting changes during or after lactate infusion, we plan to describe that in our article.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Nov 2022, 5 months.
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