NCT03356457

Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To determine the effect of re-activation of brain glucose metabolism induced by dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in patients with type 1 diabetes (T1DM) with recurrent hypoglycemia.

Detailed description

This will be a single center, placebo-controlled, cross-over, randomized clinical pilot study. The screening will take place at the Yale New Haven Hospital Research Unit (HRU) 10th floor, East Pavilion at 20 York St., New Haven, CT. At the screening visit informed consent will be obtained. Medical history and documents will be reviewed to screen potential subjects by inclusion and exclusion criteria. Subjects will receive a physical examination and laboratory blood work (BUN/creatinine, electrolytes, lipid profile, liver function, and HbA1c) as well as urine toxicology screens (to confirm self-report of alcohol, and drug information) to ensure good physical health.

Conditions

• Hyperglycaemia (Diabetic)

Interventions

Type	Name	Description
DRUG	Dichloroacetate	Dichloroacetate is an isoform-unspecific inhibitor of four regulatory pyruvate dehydrogenase kinases, which are able to reduce entry of substrates into mitochondria by reducing the conversion of pyruvate to acetyl-CoA. Drug will be administered to subjects with sever hypoglycemia as well as healthy non-diabetic subjects.
DRUG	Placebo oral capsule	A Placebo oral capsule identical in shape and color to those with active ingredient.

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-03-20
• Completion: 2019-03-20
• First posted: 2017-11-29
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study