RECRUITINGEarly Phase 1INTERVENTIONAL
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (1)
Yale-New Haven Hospital
New Haven, Connecticut, United States