Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPennington Biomedical Research Center

About this trial

Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes.

The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.

Eligibility criteria

Qualifiers

Healthy male or female

Ages 18-40 years

BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)

Medically cleared for participation in the study

Disqualifiers

Contraindication to MRI

Consume >10 alcoholic drinks/week

History of chronic smoking or have quit less than 10 years ago

History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL

Trial design

Treatments tested in this trial

  • hyperinsulinemic-hypoglycemic clamp
  • 13C-MRS procedure/Acetate infusion

Treatment groups

10 Participants
are divided into 1 treatment group