NCT03301532

Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D

Compatibility of Triheptanoin (C7) With the Ketogenic Diet in Patients Diagnosed With Glucose Transporter Type 1 Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 30 Months – 35 Years
• Healthy volunteers: Not accepted

Summary

To explore triheptanoin (C7 oil) compatibility with the ketogenic diet by evaluating EEG, and seizure rate, glycemia and ketosis in proven G1D patients receiving a ketogenic diet.

Detailed description

This is a single site, open label proof of principle exploratory trial to investigate the compatibility of C7 oil with the ketogenic diet in subjects diagnosed with G1D. The ketogenic diet will have been previously described by the patient's treating physician independently of this study and for clinical reasons. The ketogenic diet supplies over 50% of calories from fat, subjects, who are already tolerating over this much fat as part of their previously prescribed ketogenic diet, will replace 45% of their daily caloric intake with the triheptanoin for 24 hours, during a 48 hour inpatient stay. Subjects will have a continuous EEG to monitor for any potential C7 related changes in seizure before, during, and after triheptanoin oil ingestion.

Conditions

• GLUT1DS1

Interventions

Type	Name	Description
DRUG	Triheptanoin	Dietary supplementation with triheptanoin

Timeline

• Start date: 2018-06-05
• Primary completion: 2021-06-18
• Completion: 2022-07-31
• First posted: 2017-10-04
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study