Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 4
- Primary Endpoint
- Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Time Frame: Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart
Secondary Outcomes
No secondary outcomes reported
Investigators
David McDougal
Assistant Professor
Pennington Biomedical Research Center