NCT02021526

Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)

Treatment Development of Triheptanoin for Glucose Transporter Type I Deficiency

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Juan Pascual · Academic / Other
• Sex: All
• Age: 30 Months – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a single-site, open-label, phase II trial of C7, a food supplement or medical food, for the development of treatment outcome measures for glucose transporter type I deficiency (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by changes in comprehensive blood work, including lipid and free fatty acid panels, self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on ketogenic diet, as measured by serial ketone levels during treatment initiation.

Conditions

• Glucose Transporter Type 1 Deficiency Syndrome
• Glut1 Deficiency Syndrome

Interventions

Type	Name	Description
DRUG	Triheptanoin	Triheptanoin (C7 oil) is a 7-carbon medium chain triglyceride.

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2013-12-27
• Last updated: 2019-02-15

Locations

1 site across 1 country: United States