Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D (NCT03301532) | Clinical Trial Compass
CompletedPhase 2
Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D
United States10 participantsStarted 2018-06-05
Plain-language 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.
Who can participate
Age range30 Months – 35 Years
SexALL
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Inclusion Criteria:
* Diagnosis of glucose transporter type 1 deficiency (G1D), confirmed by clinical genotyping at a CLIA-certified laboratory.
* Stable on ketogenic diet at 2.5:1 to 4:1 ratio (i.e., no changes in ratio will have taken place for 2 months). The initiation of a ketogenic diet is previous to - and thus is not part of this study.
* Males and females 30 months to 35 years and 11 months old inclusive.
Exclusion Criteria:
* Subjects with evidence of independent, unrelated metabolic and/or genetic disease.
* Subjects with a chronic gastrointestinal disorder, such as irritable bowel syndrome, crohn's disease, or colitis that could increase the subject's risk of developing diarrhea or stomach pain.
* Subjects with a BMI (body mass index) greater than or equal to 30.
* Subjects currently not on ketogenic diet.
* Women who are pregnant or breast feeding may not participate. Women who plan to become pregnant during the course of the study, or who are unwilling to use birth control to prevent pregnancy (including abstinence) may not participate. Females age 10 and over will be asked to provide a urine sample for a pregnancy test via dipstick. Subjects will be asked to agree to abstinence or another form of birth control for the duration of the study.
* Allergy/sensitivity to C7
* Previous use of triheptanoin less than 1 month prior to study initiation.
* Treatment with medium chain triglycerides in the last 24 hours.
* Subjects exhibiting signs of dementia, or diagnose…
What they're measuring
1
Change in Ketosis (Beta-hydroxybutyrate Levels)
Timeframe: Day 1, Day 4
Trial details
NCT IDNCT03301532
SponsorUniversity of Texas Southwestern Medical Center