Diabetes, Hypoglycemia
Conditions
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).
Interventions
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.
DEVICEContinuous glucose monitoring
Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS) | Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart |
Countries
United States
Outcome results
None listed