drugset / Trial / NCT03738852
Mechanisms for Restoration of Hypoglycemia Awareness
Phase 0
Completed
55 enrolled
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.
Timeline
- Start
- 2018-11-07
- Primary completion
- 2023-08-14
- Completion
- 2023-08-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Insulin | Protein / enzyme biologic | — | — |