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Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Study acronym: E-VAL
StatusSuspended
PhaseNot applicable
Started
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Record History

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  1. Recruitment suspended Sponsor's reason: Study activities are temporarily on hold. Recruitment may resume in the future. Show 5 more changesShow less
    • Primary completion pushed from Jun 2026 to Jul 2027
    • Study completion pushed from Sep 2026 to Oct 2027
    • Interventions: 13C-MRS procedure/Acetate infusion (Other), hyperinsulinemic-hypoglycemic clamp (Other) to 13C-MRS procedure/Acetate infusion (Other), hyperinsulinemic-hypoglycemic clamp (Other)
    • Eligibility criteria expanded, about 14 words
    • Site details revised
  2. Primary completion date: Jun 2025 to Jun 2026
    • Study completion date: Sep 2025 to Sep 2026
    v11
  3. Primary completion date: Jun 2024 to Jun 2025
    • Study completion date: Sep 2024 to Sep 2025
    v10
  4. Primary completion date: Jun 2023 to Jun 2024
    • Study completion date: Sep 2023 to Sep 2024
    v9
  5. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Nov 2022 to Jun 2023
    • Study completion date: Mar 2023 to Sep 2023
    • Site details revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Dec 2021 to Nov 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2022 to Mar 2023
    • Site details revised
    v7
  2. Primary completion date: Oct 2021 to Dec 2021
    • Study completion date: Dec 2021 to Mar 2022
    v6
  3. Primary completion date: Aug 2021 to Oct 2021
    • Study completion date: Aug 2021 to Dec 2021
    v5
  4. Primary completion date: Feb 2021 to Aug 2021v4
  5. Trial status: Suspended to Recruiting
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: COVID-19 outbreakv2 Show 4 more changesShow less
    • Phase: Not specified to Not applicable
    • Start date changed from estimate of Feb 2020 to Feb 19, 2020
    • Study arms: 0 to 1
    • Secondary endpoints expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04207619
Lead Sponsor Pennington Biomedical Research Center
Conditions
(from sponsor)		 Diabetes, Hypoglycemia
Related terms Diabetes Mellitus, Hypoglycemia
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov