Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)

Epilepsy Clinical Trial

Official title: Dietary Treatment of Glucose Transporter Type 1 Deficiency (G1D)

Status Active, not recruiting

Clinical Trial Summary

Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in addition to IQ, language, working memory, processing speed, emotional and behavioral functioning, ataxia, and other neuropsychological and neurological performance indices in children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.

Clinical Trial Description

This is an open-label, single arm trial of orally-administered C7 in G1D. Subjects will replace a fixed percentage of their daily caloric intake (based on the results of Protocol 1) with C7 for 6 months, undergo full evaluation and discontinuation of treatment at a 6 month visit, and return for an off-treatment follow up visit 3 months after C7 oil discontinuation, for total duration of participation of 9 months. Subjects will undergo treatment initiation on a 24-hour inpatient basis. During that 24-hr inpatient treatment initiation, subjects will have continuous EEG both to monitor for real-time seizure activity (for safety) and to determine EEG changes (secondary outcome) before, during, and after treatment initiation. Subjects will undergo clinical evaluation, comprehensive blood work, ataxia scale rating, EEG, and neuropsychological testing at baseline, 6 months, and 9 months. ;

Related Conditions & MeSH terms

• Epilepsy
• Glucose Metabolism Disorders
• Glucose Transport Defect
• Glucose Transporter Protein Type 1 Deficiency Syndrome
• Glucose Transporter Type 1 Deficiency Syndrome
• Glut1 Deficiency Syndrome 1, Autosomal Recessive
• GLUT1DS1
• Metabolic Diseases
• Syndrome

• NCT number: NCT03181399
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 18, 2018
• Completion date: September 30, 2024