Status:
RECRUITING
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Lead Sponsor:
Yale University
Conditions:
Diabetes Mellitus, Type 1
Hypoglycemia Unawareness
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Age \< 18 years or \>55 years.
- Body weight \>85 kg at screening visit
- BMI \> 30 (female) and \>30 (male) kg/m2.
- Untreated proliferative retinopathy
- carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05317455
Start Date
May 13 2025
End Date
June 30 2026
Last Update
July 3 2025
Active Locations (1)
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1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510