RightFit
RecruitingEarly Phase 1

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how dichloroacetate affects brain function when blood sugar is kept at a low level. It is for people with type 1 diabetes who have had very low blood sugar or do not notice when their blood sugar is low. The study compares the drug with a placebo, a treatment with no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have type 1 diabetes and meet at least one of the conditions below.
  • You have had very low blood sugar, do not notice when your blood sugar is low, or both.
  • You have had blood sugar below 54 mg/dL and needed another person’s help. You recovered after getting sugar by mouth, glucose through a vein, or glucagon.
  • You had at least 2 blood sugar readings below 54 mg/dL during continuous glucose monitor testing. The listing describes 2 weeks of testing but also says testing was during the week before the study.

Who can't join

  • You are younger than 18 or older than 55.
  • You weigh more than 85 kg at the screening visit.
  • Your body mass index (BMI), a measure based on height and weight, is over 30.
  • You have untreated proliferative retinopathy, an eye disease with abnormal blood vessel growth.
  • You have certain changes in the GSTZ-1 gene that can cause dichloroacetate to build up in your body and cause harm.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CT