Effect of Dichloroacetate on Brain Function in Type 1 Diabetes During Hypoglycemia
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
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 |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05317455 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with Type 1 Diabetes who have a history of severe hypoglycemia or hypoglycemia unawareness.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.