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

Pennington Biomedical Research Center

Status: Completed

Conditions: Hypoglycemia; Diabetes

Treatments: Other: 13C-MRS procedure/Acetate infusion; Device: Continuous glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04430660

PBRC 2018-060

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Arm 1

Other group

Description:

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.

Treatment:

Device: Continuous glucose monitoring

Other: 13C-MRS procedure/Acetate infusion