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OpenTrials
Completed

NCT Number: NCT03738852

Mechanisms for Restoration of Hypoglycemia Awareness

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.

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Key information

Conditions

Type1 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor (CGM)

Device

Continuous Glucose Monitor (CGM)

Other names: Dexcom G6

Insulin

Drug

standard insulin regimen

Primary outcomes

  1. Brain Glucose Levels

    Time frame: 3 months

    Regional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2018
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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