Effects of sodium lactate infusion in patients with glucose transporter 1 deficiency syndrome (GLUT1DS)

Phase 2

Completed

Conditions: Glucose transporter 1 deficiency syndrome
GLUT1
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10018424
10039911

Registration Number: NL-OMON48362

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in frequency or form of epileptic discharges on EEG.<br /><br>The change in EEG will be measured by a neurologist experienced in reading<br /><br>EEG*s.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Seizure frequency: Subjects will be recorded on video camera and seizures will<br /><br>be monitored.<br /><br>Laboratory measures: All measurements will be performed in blood samples, and<br /><br>all samples will be analysed in laboratories of the Radboudumc.<br /><br>- lactate concentration<br /><br>- pH<br /><br>- glucose<br /><br>- sodium<br /><br>- potassium<br /><br>- chloride<br /><br>- bicarbonate</p><br>