Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Phase 1

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1; Hypoglycemia Unawareness

• Registration Number: NCT05317455
• Lead Sponsor: Yale University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-3-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Inclusion Criteria:<br><br>T1DM subjects with:<br><br> - a history of severe hypoglycemia and/or hypoglycemia unawareness or<br><br> - a history of severe hypoglycemia with a blood glucose <54 mg/dL, requiring the<br> assistance of another person (with recovery after the administration of oral<br> carbohydrate, intravenous glucose, or glucagon) or<br><br> - at least 2 values <54mg/dl during 2 weeks of CGMS testing during the week prior to<br> study.<br><br>Exclusion Criteria:<br><br> - Age < 18 years or >55 years.<br><br> - Body weight >85 kg at screening visit<br><br> - BMI > 30 (female) and >30 (male) kg/m2.<br><br> - Untreated proliferative retinopathy<br><br> - carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose<br> to DCA accumulation and toxicity

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Function

Secondary Outcome Measures

Name	Time	Method
Brain glucose metabolism