Regulation of Brain Glucose Metabolism in Type 1 Diabetes (NCT05317455) | Clinical Trial Compass
RecruitingEarly Phase 1
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
United States16 participantsStarted 2025-05-13
Plain-language summary
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 can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying people with Type 1 diabetes and hypoglycemia unawareness — does my situation match what they're looking for, and is that something worth exploring with my care team?
2Since this is an Early Phase 1 study focused on how the brain uses glucose during low blood sugar, what does that phase mean in terms of what researchers already know about safety, and what unknowns should I be aware of before considering it?
3The trial is measuring cognitive function as its main outcome — can you help me understand what kinds of tests or procedures that might involve, and whether any of them could trigger a hypoglycemic episode that I'd need to be prepared for?
4Given that this study is about brain glucose metabolism rather than a new drug or device, how does it compare to just focusing on improving my hypoglycemia awareness through my current treatment plan or a continuous glucose monitor?
5If I were to participate in a research study like this one, how might the time commitment and any required low blood sugar episodes affect my daily life and diabetes management?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.