Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03301532|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : December 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|GLUT1DS1||Drug: Triheptanoin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compatibility of Triheptanoin (C7) With the Ketogenic Diet in Patients Diagnosed With Glucose Transporter Type 1 Deficiency|
|Actual Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||July 5, 2021|
|Estimated Study Completion Date :||July 5, 2023|
Experimental: Patients on a ketogenic diet
This is a one arm study were patients will be receiving an oil called triheptanoin. Patients will be consuming triheptanoin 4 times over the course of one day. The triheptanoin oil will take up 45% of their daily calories on the day the day they are taking the oil.
Dietary supplementation with triheptanoin
Other Name: C7 oil
- Ketosis [ Time Frame: 3 years ]Changes in blood betahydroxybutyric acid level.
- EEG [ Time Frame: 3 years ]Changes in abnormal EEG discharges.
- Seizure rate [ Time Frame: 3 years ]Changes in observable seizure numbers.
- Glycemia [ Time Frame: 3 years ]Changes in blood glucose levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301532
|Contact: Adrian Avila, BSemail@example.com|
|Contact: Tricia Plumb, R.N.||firstname.lastname@example.org|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Contact: Adrian Avila, B.S. 214-648-4591 email@example.com|
|Contact: Juan M Pascual, M.D. 214-648-3562 firstname.lastname@example.org|
|Principal Investigator: Juan M Pascual, M.D.|
|Principal Investigator:||Juan Pascual, M.D.||Study Principal Investigator|