Trial · NCT03181399
Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)
NCT03181399, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2025-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Diet Treatment Glucose Transporter Type 1 Deficiency (G1D). Trials, record NCT03181399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03181399
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)
- NCT number
- NCT03181399
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
GLUT1DS1, Epilepsy, Glut1 Deficiency Syndrome 1, Autosomal Recessive, Glucose Metabolism Disorders, Glucose Transport Defect, Glucose Transporter Type 1 Deficiency Syndrome, Glucose Transporter Protein Type 1 Deficiency Syndrome
- Interventions
- Triheptanoin
- First posted
- 2017-06-08
- Last updated
- 2025-08-07
- Results first posted
- 2025-04-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neuropsychological Score of Sustained Attention | Change post 6 months of treatment | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The number of participants that showed a decrease in the CPT HRT BC score after 6 months of treatment as compared to baseline is noted here. |
| Primary | Neuropsychological Score of Sustained Attention | Change after 3 months off treatment | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in CPT HRT BC score (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. |
| Primary | Neuropsychological Score of Working Memory Index Scale (WMI) | Change post 6 months of treatment | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The number of participants that showed an increase in the WMI score after 6 months of treatment is noted here. |
| Primary | Neuropsychological Score of Working Memory Index Scale (WMI) | Change after 3 months off-treatment | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. |
| Primary | Neuropsychological Score of Processing Speed Index (PSI) | Change post 6 months of treatment | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The number of participants that showed an increase in the PSI score after 6 months of treatment as compared to baseline is noted here. |
| Primary | Neuropsychological Score of Processing Speed Index (PSI) | Change after 3 months off-treatment | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. |
| Secondary | EEG Changes: Generalized Spike Wave Activity and Burst | Change post 6 months of treatment | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The number of patients that displayed a decrease in GSW and burst per hour after 6 months of treatment in noted here. |
| Secondary | EEG Changes: Generalized Spike Wave Activity and Burst | Change after 3 months off-treatment | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in GSW and burst per hour (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. |
| Secondary | Brief Ataxia Rating Scale | Change post 6 months of treatment | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The number of participants that showed a decrease in BARS score after 6 months of intervention is reported here. |
| Secondary | Brief Ataxia Rating Scale | Change after 3 months off treatment | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a subsequent increase in BARS score (towards baseline) after the of 3 months of no treatment as compared to 6 months on treatment are recorded here. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neuropsychological Score of Sustained Attention | Change post 6 months of treatment | Although 29 patients completed the 6-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neuropsychological Score of Sustained Attention | Change after 3 months off treatment | Although 28 patients completed the 3-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neuropsychological Score of Working Memory Index Scale (WMI) | Change post 6 months of treatment | Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neuropsychological Score of Working Memory Index Scale (WMI) | Change after 3 months off-treatment | Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neuropsychological Score of Processing Speed Index (PSI) | Change post 6 months of treatment | Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neuropsychological Score of Processing Speed Index (PSI) | Change after 3 months off-treatment | Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | EEG Changes: Generalized Spike Wave Activity and Burst | Change post 6 months of treatment | Out of 45 enrolled, 29 patients completed the 6 month treatment period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | EEG Changes: Generalized Spike Wave Activity and Burst | Change after 3 months off-treatment | Out of 29 patients who completed the treatment period, 28 returned for the 3 month off-treatment visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Brief Ataxia Rating Scale | Change post 6 months of treatment | Although 29 patients completed the study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to complete it. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Brief Ataxia Rating Scale | Change after 3 months off treatment | Although 28 patients completed the off-treatment phase of study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to comprehend it. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neuropsychological Score of Sustained Attention | Triheptanoin | 11 | Participants | ||
| Neuropsychological Score of Sustained Attention | Triheptanoin | 14 | Participants | ||
| Neuropsychological Score of Working Memory Index Scale (WMI) | Triheptanoin | 7 | Participants | ||
| Neuropsychological Score of Working Memory Index Scale (WMI) | Triheptanoin | 5 | Participants | ||
| Neuropsychological Score of Processing Speed Index (PSI) | Triheptanoin | 6 | Participants | ||
| Neuropsychological Score of Processing Speed Index (PSI) | Triheptanoin | 7 | Participants | ||
| EEG Changes: Generalized Spike Wave Activity and Burst | Triheptanoin | GSW/hr | 10 | Participants | |
| EEG Changes: Generalized Spike Wave Activity and Burst | Triheptanoin | Bursts/hr | 7 | Participants | |
| EEG Changes: Generalized Spike Wave Activity and Burst | Triheptanoin | GSW/hr | 13 | Participants | |
| EEG Changes: Generalized Spike Wave Activity and Burst | Triheptanoin | Bursts/hr | 11 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 6 Months on Treatment | STARTED | Triheptanoin | 45 | |
| 6 Months on Treatment | COMPLETED | Triheptanoin | 29 | |
| 6 Months on Treatment | NOT COMPLETED | Triheptanoin | 16 | |
| 3 Months Off-treatment | STARTED | Triheptanoin | 29 | |
| 3 Months Off-treatment | COMPLETED | Triheptanoin | 28 | |
| 3 Months Off-treatment | NOT COMPLETED | Triheptanoin | 1 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild nausea | Gastrointestinal disorders | Triheptanoin | 9 | 45 | |
| other | Mild vomiting | Gastrointestinal disorders | Triheptanoin | 22 | 45 | |
| other | Diarrhea | Gastrointestinal disorders | Triheptanoin | 29 | 45 | |
| other | Upset stomach | Gastrointestinal disorders | Triheptanoin | 10 | 45 | |
| other | Stomach pain or cramping | General disorders | Triheptanoin | 10 | 45 | |
| other | Acid reflux | Gastrointestinal disorders | Triheptanoin | 2 | 45 | |
| other | Fatigue | General disorders | Triheptanoin | 4 | 45 | |
| other | Constipation | Gastrointestinal disorders | Triheptanoin | 2 | 45 | |
| other | Seizure | Nervous system disorders | Triheptanoin | 7 | 45 | |
| other | Hypoglycemia | General disorders | Triheptanoin | 2 | 45 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triheptanoin | 0 | 45 |
| Total, other adverse events | Triheptanoin | 41 | 45 |
| Total, serious adverse events | Triheptanoin | 0 | 45 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS094257 | Dietary treatment of Glut1 deficiency (G1D) - Revision - 1 | PASCUAL, JUAN M. | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2016 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Continuous Performance Test | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03181399
GET https://conductscience.org/api/trials/v1/NCT03181399/registered