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

Purpose

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).

Conditions

  • Diabetes
  • Hypoglycemia

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Arm 1 		Participants will have there glial acetate metabolism assessed via 13C MRS at baseline and then again 14 days later. Participants will wear blinded continuous glucose monitoring devices for ~4 weeks.
  • Other: 13C-MRS procedure/Acetate infusion
    Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.
  • Device: Continuous glucose monitoring
    Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
    Other names:
    • CGM

More Details

Status
Completed
Sponsor
Pennington Biomedical Research Center

Study Contact