Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
⁃ T1DM subjects with:
• a history of severe hypoglycemia and/or hypoglycemia unawareness or
• a history of severe hypoglycemia with a blood glucose \<54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
• at least 2 values \<54mg/dl during 2 weeks of CGMS testing during the week prior to study.
Locations
United States
Connecticut
Yale-New Haven Hospital
RECRUITING
New Haven
Contact Information
Primary
Alice Hahn
alice.hahn@yale.edu
4753210504
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 16
Treatments
Placebo_comparator: Placebo
oral solution with flavoring agent, no active drug.
Active_comparator: Dichloroacetate
oral solution of dichloroacetate with flavoring agent
Related Therapeutic Areas
Sponsors
Leads: Yale University