Mechanisms for Restoration of Hypoglycemia Awareness

Type1 Diabetes Mellitus Clinical Trial

Official title:

Mechanisms for Restoration of Hypoglycemia Awareness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738852
• Other study ID #: 2000023189
• Secondary ID: 2R01DK020495-42
• Status: Completed
• Phase: Early Phase 1
• Start date: November 7, 2018
• Est. completion date: August 14, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (CNS) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (CNS) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of T1DM patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type1 Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitor (CGM)
Continuous Glucose Monitor (CGM)

Drug:
• Insulin
standard insulin regimen

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain glucose levels	Brain glucose will be lower and brain activation higher in those receiving continuous glucose monitor Rx.	3 months