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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Dichloroacetate
DrugDichloroacetate has a long safety record of administration to humans with a rare metabolic disorder for over 40 years. It has been given orally to patients with T2DM for up to a week without any problems and other laboratory or significant clinical adverse effects were not noted. It activates mitochondrial PDH flux, a key regulator of glucose oxidation.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: DichloroacetateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Function
Measures of reaction time \[in milliseconds\] and cognitive testing performance under hypoglycemia \[percentage\].
Time frame
1 daySecondary outcomes
1
Brain glucose metabolism
Measurement of brain glucose metabolism under hypoglycemia.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov