Sodium Lactate Infusion in GLUT1DS Patients
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|ClinicalTrials.gov Identifier: NCT04112862|
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|GLUT1 Deficiency Syndrome GLUT1DS1 GLUT1DS2 Epilepsy Lactic Acid Blood Increased Ketogenic Dieting||Other: sodiumlactate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single center, interventional, explorative, open label, proof of principle study|
|Masking:||None (Open Label)|
|Official Title:||Effects of Sodium Lactate Infusion in Patients With Glucose Transporter 1 Deficiency Syndrome (GLUT1DS)|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||April 2020|
three GLUT1DS patients with drug resistant epilepsy who tried the ketogenic diet without any benefits.
intravenous sodiumlactate 600mmol/L
- Number of changes in epileptic discharges on EEG during the infusion of lactate. [ Time Frame: 1 day ]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.
- Change in seizure frequency clinical visible by caregivers during and after infusion of sodium lactate. [ Time Frame: 1 day ]All subjects have frequent seizures, we want to see if these clinically visible seizures reduce during or after infusion with sodium lactate.
- 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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112862