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Phase COVID-NA

Mechanisms for restoration of hypoglycemia awareness

  • Study HIC#:2000023189
  • Last Updated:01/01/0001

Determine the impact of frequent hypoglycemia and hypoglycemia unawareness on brain responses to visual food cues as well as brain functional connectivity in T1DM patients. Aim 2: Assess the impact of antecedent bouts of hypoglycemia on brain glucose transport/metabolism during hyperglycemia in T1DM Unaware, T1DM Aware as well as healthy controls using 1H, 13C magnetic resonance spectroscopy (MRS). Aim 3: Determine if reducing hypoglycemia and glycemic variability using closed loop insulin delivery reverses altered brain glucose transport/metabolism and functional connectivity in hypoglycemia unaware T1DM patients.

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    For more information about this study, including how to volunteer, contact:

    Mari-Lynet Knight

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    Trial Purpose and Description

    Aim 1: Determine the impact of frequent hypoglycemia and hypoglycemia unawareness on brain responses to visual food cues as well as brain functional connectivity in T1DM patients. 

    Aim 2: Assess the impact of antecedent bouts of hypoglycemia on brain glucose transport/metabolism during hyperglycemia in T1DM Unaware, T1DM Aware as well as healthy controls using 1H, 13C magnetic resonance spectroscopy (MRS).

    Aim 3: Determine if reducing hypoglycemia and glycemic variability using closed loop insulin delivery reverses altered brain glucose transport/metabolism and functional connectivity in hypoglycemia unaware T1DM patients. 

    Eligibility Criteria

    Inclusion Criteria:

     Ages > 18 years

    Healthy, non-diabetic control or T1DM (with HbA1C < 8%)

    BMI > 18.0

    Exclusion Criteria:

     Creatinine > 1.5 mg/dL

     Hgb < 10 mg/dL

     ALT > 2.5 X ULN

     untreated thyroid disease

     uncontrolled hypertension

     neurologic disorders

    psychiatric disorders

     use of psychiatric medication

     greater than 5% change in weight in last 3 months

     malignancy

    smoking

    current or recent steroid use in last 3 months

    Principal Investigator

    Sub-Investigators

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