Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Launched by YALE UNIVERSITY · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how a medication called dichloroacetate might help improve brain function in people with Type 1 Diabetes (T1D) during low blood sugar episodes, which can be very dangerous. The study will focus on individuals who have had serious low blood sugar situations and may not be able to feel when their blood sugar is dropping, a condition known as hypoglycemia unawareness.

To participate in this trial, you must be between 19 and 55 years old and have a history of severe low blood sugar, like needing help from someone else when your blood sugar drops below 54 mg/dL. Participants will be randomly assigned to receive either the medication or a placebo (a sugar pill) during different periods of the study, and neither they nor the researchers will know which they are receiving at any given time. This helps ensure that the results are reliable. The trial is not yet recruiting, but if you're interested, it might be a great opportunity to contribute to important research that could improve care for people with Type 1 Diabetes.

Gender

ALL

Eligibility 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