Regulation of Brain Glucose Metabolism in Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dichloroacetate.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1, Hypoglycemia Unawareness. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.
Interventions
- Drug Dichloroacetate
Dichloroacetate 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.
Primary outcome measures
- Cognitive Function [Time frame: 1 day]
Secondary outcome measures (1)
- Brain glucose metabolism [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale-New Haven Hospital — New Haven
Identifiers
NCT: NCT05317455 · 2000035036