Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients

Last updated: March 7, 2023
Sponsor: Pennington Biomedical Research Center
Overall Status: Completed

Phase

N/A

Condition

Hormone Deficiencies

Diabetic Macular Edema

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT04430660
PBRC 2018-060
  • Ages 18-40
  • All Genders

Study Summary

A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common complication of diabetes treatment and is a major barrier to the maintenance of healthy glucose levels in individuals with diabetes. The primary purpose of the study is to test the proof-of-concept that there is an association between the rate of GAM and susceptibility to insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be measured in a patient population known to frequently experience hypoglycemia, i.e., individuals with type 1 diabetes mellitus (T1DM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female
  • Ages 18-40 years
  • Diagnosed with type 1 diabetes with positive antibodies or dependent on insulintherapy
  • HbA1c of ≤8.5%
  • Modified Clarke's Hypoglycemia Questionnaire score of 12-24
  • Willing to participate in continuous glucose monitoring (CGM)

Exclusion

Exclusion Criteria:

  • Contraindication to MRI
  • Consume >10 alcoholic drinks/week
  • Current use of CGM
  • Current use of insulin pump
  • Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.
  • Current use of steroids, e.g. cortisone, and prednisone.
  • History of chronic smoking or have quit less than 10 years ago
  • History of cancer in the past 5 years (individuals with basal cell or squamous cellskin cancer would be allowed)
  • History of seizures
  • Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic,rheumatologic, or psychiatric disease
  • Significant liver disease as defined as more than twice the upper limit of normal forliver enzymes
  • Significant renal disease as defined as a estimated glomerular filtration rate lessthan 30
  • Pregnant, planning to become pregnant, or breastfeeding
  • Have been hospitalized or treated in the past 3 months for severe hypoglycemia
  • Based on the investigative team's clinical judgement, a subject may not be appropriatefor participation in the study.

Study Design

Total Participants: 8
Study Start date:
August 19, 2020
Estimated Completion Date:
May 04, 2022

Connect with a study center

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808-4124
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

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