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

Not Applicable

Completed

• Conditions: Hypoglycemia; Diabetes

• Registration Number: NCT04430660
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Study Start: 2020-08-19
• Primary Completion: 2022-03-29
• Study Completion: 2022-05-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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 cell skin 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 for liver enzymes
• Significant renal disease as defined as a estimated glomerular filtration rate less than 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 appropriate for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)	Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart

Trial Locations

Locations (2)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, United States