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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.