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Sodium Lactate Infusion in GLUT1DS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112862
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
This study investigates the effect of lactate infusion on epileptic discharges on EEG and seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.

Condition or disease Intervention/treatment Phase
GLUT1 Deficiency Syndrome GLUT1DS1 GLUT1DS2 Epilepsy Lactic Acid Blood Increased Ketogenic Dieting Other: sodiumlactate Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single center, interventional, explorative, open label, proof of principle study
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Intervention
three GLUT1DS patients with drug resistant epilepsy who tried the ketogenic diet without any benefits.
Other: sodiumlactate
intravenous sodiumlactate 600mmol/L




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Concentration of lactate in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  3. Concentration of glucose in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  4. Concentration of sodium in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  5. Concentration of potassium in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  6. Concentration of bicarbonate in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  7. Concentration of chloride in blood during and after sodium lactate infusion [ Time Frame: 1 day ]
  8. pH in blood during and after sodium lactate infusion [ Time Frame: 1 day ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with GLUT1DS and known in our center.
  • Baseline characteristics include a high frequency of clinical seizures and epileptic discharges on EEG.
  • History of trying ketogenic diet with good compliance without beneficial effects.
  • Age > 6 years.
  • Informed consent.

Exclusion Criteria:

  • Additional medical condition or illness that impairs the patient's ability to participate in the study (for example actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant haematological or biochemical abnormalities).
  • Elevated serum sodium (> 145 mmol/L).
  • Participation in another interventional study at start of the study or during the study.
  • Presence of known panic disorders or a history of panic attacks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112862


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500GA
Contact: Michèl AAP Willemsen, MD, PhD    0031243613396    michel.willemsen@radboudumc.nl   
Contact: Loes A van Gemert, MSc    0031243613396    loes.vangemert@radboudumc.nl   
Sponsors and Collaborators
Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04112862    
Other Study ID Numbers: 109147
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
GLUT1 deficiency syndrome
sodium lactate infusion
epilepsy
Additional relevant MeSH terms:
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Epilepsy
Hyperlactatemia
Syndrome
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases