Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorYale University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Age < 18 years or >55 years.
Body weight >85 kg at screening visit
BMI > 30 (female) and >30 (male) kg/m2.
Untreated proliferative retinopathy
Trial design
Treatments tested in this trial
- Dichloroacetate
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov