Effect of Dichloroacetate on Brain Function in Type 1 Diabetes During Hypoglycemia
Official title: Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Run by Yale University · NCT05317455 · Data updated 2026-11-12
This study is testing if a drug called dichloroacetate can help people with Type 1 Diabetes think better during low blood sugar episodes by improving how their brains use glucose.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | May 13, 2025 |
| Main results expected | May 1, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT05317455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 55 with Type 1 Diabetes who have a history of severe hypoglycemia or hypoglycemia unawareness.
✕Probably not a fit
Patients outside the age range of 18 to 55, those with untreated proliferative retinopathy, or those with certain genetic predispositions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study investigates how dichloroacetate (DCA) can influence brain glucose metabolism in individuals with Type 1 Diabetes (T1D) who experience cognitive deficits during hypoglycemia. It employs a prospective randomized placebo-controlled double-blind crossover design, where participants will receive DCA and a placebo under controlled hypoglycemic conditions. The goal is to determine if DCA can restore brain glucose metabolism and improve cognitive function during episodes of low blood sugar. Participants will be closely monitored to assess the effects of the intervention on brain function.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function in T1D patients experiencing hypoglycemia, enhancing their quality of life and safety.
How similar studies have gone: While the approach of using DCA in this context is novel, similar studies have explored interventions for cognitive function in diabetes, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Yale-New Haven Hospital
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Raimund Herzog, MD — Yale University
- Study coordinator: Alice Hahn
- Email: alice.hahn@yale.edu
- Phone: 4753210504
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tirzepatide for type 1 diabetes patients who are overweight or obese
This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.
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Genetic risk score and progression to insulin in type 1 diabetes
This study tests whether a genetic risk score can predict which people with type 1 diabetes will need insulin progression over three years.
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Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes
This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.
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Diabetes multimorbidity and a voice diary app to help self-manage
This study tests whether the Fabla-diabetesMM audio diary app is feasible and helpful for older adults with type 1 or type 2 diabetes who also have additional chronic conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.