Mechanisms for Restoration of Hypoglycemia Awareness

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Ages > 18 years

• Healthy, non-diabetic control or T1DM

• BMI > 18.0

Exclusion Criteria:

• Creatinine > 1.5 mg/dL

• Hct < 35% for females, < 39% for males

• ALT > 2.5 X ULN

• untreated thyroid disease

• uncontrolled hypertension

• neurologic disorders

• untreated depression or change in antidepressant regimen in last 3 months

• use of any anxiolytic medications (benzodiazepine) or antipsychotic medications

• greater than 5% change in weight in last 3 months

• malignancy

• current or recent steroid use in last 3 months

• illicit drug use

• significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)

• inability to enter MRI (per standard MRI safety guidelines)

• for women: pregnancy or breastfeeding