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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02021526 |
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Date of registration:
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12/12/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)
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Scientific title:
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Treatment Development of Triheptanoin for Glucose Transporter Type I Deficiency |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02021526 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Juan Pascual, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis or suspected diagnosis of glucose transporter type I deficiency (G1D).
- On stable ketogenic diet at a ratio between 1:2.5 and 1:4 OR Stable on no dietary
therapy
- Males and females 30 months to 55 years old, inclusive.
Exclusion Criteria:
- Subjects with a history of life-threatening seizure episodes, including but not
limited to status epilepticus and cardiac arrest.
- Subjects with a BMI (body mass index) greater than or equal to 30 will be excluded.
- Subjects currently on dietary therapy other than ketogenic diet (i.e., medium chain
triglyceride-supplemented diets, Atkins diet, low glycemic index diet, etc.).
- 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.
- Allergy/sensitivity to triheptanoin.
- Previous treatment with triheptanoin.
- Treatment with medium chain triglycerides in the last 30 days.
- Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain
disorder (such as Alzheimer's disease) that would confound assessment of cognitive
changes, in the opinion of the investigator.
- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements.
- Patients with metal implants, experience claustrophobia, or who are behaviorally
unable to be still for MRS (magnetic resonance spectroscopy) imaging (not due to
seizures) will be excluded from the imaging portion of the research.
- Inability or unwillingness of subject or legal guardian/representative to give written
informed consent, or assent for children age 10-17.
Age minimum:
30 Months
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glucose Transporter Type 1 Deficiency Syndrome
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Glut1 Deficiency Syndrome
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Intervention(s)
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Drug: Triheptanoin
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Primary Outcome(s)
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Change in Ketosis
[Time Frame: baseline, 6 months, 9 months]
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Change on Biomarkers
[Time Frame: Baseline, 6 months, 9 months]
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Change in risk for Metabolic Syndrome
[Time Frame: Baseline, 6 months, 9 months]
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Secondary ID(s)
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PASCG1D2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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