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Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.
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.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
Yes
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Start Date
February 19, 2020
Primary Completion Date
June 1, 2026
Completion Date
September 1, 2026
Last Updated
July 24, 2025
10
ESTIMATED participants
hyperinsulinemic-hypoglycemic clamp
OTHER
13C-MRS procedure/Acetate infusion
OTHER
Lead Sponsor
Pennington Biomedical Research Center
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03970720