Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04311307 | Endogenous Glucose Production in Patients With Glycogen Storage Disease Type Ia | PHASE1 | COMPLETED | 20 | — | — | Jan 19, 2021 | Feb 7, 2022 | Feb 11, 2022 | 1 | Netherlands |
Endogenous glucose production (EGP) in GSDIa will be assessed through minimal model calculation
| Arm | Type | Description |
|---|---|---|
| Patients | EXPERIMENTAL | GSDIa patients |
| Controls | ACTIVE_COMPARATOR | Healthy volunteers |
| Name | Type | Description |
|---|---|---|
| [6,6-2H2]glucose | BIOLOGICAL | Each subject will be administered two oral \[6,6-2H2\]glucose loads (pre-prandial, fed) in the hospital setting and one oral \[6,6-2H2\]glucose load at home setting (random time). Capillary blood samples will be collected on filter paper 10 times at specific time points after each oral \[6,6-2H2\]glucose load. |
Inclusion Criteria: * The diagnosis should be confirmed by G6PC mutation analysis * Age above 16 years * Stable medical condition before the start of the test procedures Exclusion Criteria: * Age \< 16 years * Intercurrent illness * Recent history of hospitalization due to hypoglycemia * Pregnanc...