NCT05317455RecruitingEarly phase 1
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 30 Mar 2022
- Start date
- 13 May 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Yale University
- Diseases
- Type 1 diabetes
- NCT number
- NCT05317455
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 16
- From 13 May 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age \< 18 years or \>55 years.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.