Skip to main content
Clinical Trials/NCT04430660
NCT04430660CompletedNot Applicable

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.

Pennington Biomedical Research Center4 sites in 1 country8 target enrollmentStarted: August 19, 2020Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David McDougal

Assistant Professor

Pennington Biomedical Research Center

Study Sites (4)

Loading locations...

Similar Trials