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NCT04207619 · ClinicalTrials.gov registry record · NA

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

A NA study of Diabetes and Hypoglycemia, sponsored by Pennington Biomedical Research Center.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT04207619 is a NA study of Diabetes and Hypoglycemia that is actively recruiting participants, run by Pennington Biomedical Research Center. The registered enrollment target is 10 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04207619, a NA study of Diabetes and Hypoglycemia, is actively recruiting participants, sponsored by Pennington Biomedical Research Center.

RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Interventions

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

Study Locations (1)

Louisiana

  • Pennington Biomedical Research Center - Baton Rouge

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-02-19
Est. Completion 2026-09
Phase NA

What the Registry Record Tells You About NCT04207619

The ClinicalTrials.gov registry entry for NCT04207619 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (100% lower). The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which hyperinsulinemic-hypoglycemic clamp is the first listed.

NCT04207619 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.

Frequently Asked Questions

What is clinical trial NCT04207619 about?

NCT04207619 is a clinical study titled "Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation". 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 p...

What is the current status of trial NCT04207619?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2020-02-19. Estimated completion is 2026-09.

What conditions does trial NCT04207619 study?

This clinical trial studies the following conditions: Diabetes, Hypoglycemia.

What interventions are being tested in trial NCT04207619?

The interventions under investigation include: hyperinsulinemic-hypoglycemic clamp (OTHER), 13C-MRS procedure/Acetate infusion (OTHER).

Who is sponsoring clinical trial NCT04207619?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04207619 being conducted?

This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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