Clinical Trial: Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Treatment Development of Triheptanoin for Glucose Transporter Type I Deficiency
Brief 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.
Detailed Summary:
Sponsor: Juan Pascual
Current Primary Outcome:
- Change in risk for Metabolic Syndrome [ Time Frame: Baseline, 6 months, 9 months ]Triglycerides, lipid levels, and cholesterol are measured to evaluate change in risk of metabolic syndrome
- Change on Biomarkers [ Time Frame: Baseline, 6 months, 9 months ]EEG and brain metabolic rate will be measured at three time points. Changes in these biomarkers indicate the utilization of triheptanoin in brain metabolism
- Change in Ketosis [ Time Frame: baseline, 6 months, 9 months ]Safety blood work (described in the first outcome measure) is measured along with ketone levels and EEG to confirm that triheptanoin is safe and does not break ketosis in patients on the ketogenic diet
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: December 12, 2013
Date Started: December 2014
Date Completion: June 2019
Last Updated: December 26, 2013
Last Verified: December 2013
