Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT04207619

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Led by Pennington Biomedical Research Center · Updated on 2025-07-24

10

Participants Needed

1

Research Sites

340 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female
  • Ages 18-40 years
  • BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 accepted)
  • Medically cleared for participation in the study
Not Eligible

You will not qualify if you...

  • Contraindication to MRI
  • Consume more than 10 alcoholic drinks per week
  • History of chronic smoking or quit less than 10 years ago
  • History of clinically diagnosed diabetes or fasting blood glucose >126 mg/dL
  • Average screening blood pressure >140/90 mmHg
  • History of cardiovascular disease
  • Pregnant, planning pregnancy, or breastfeeding
  • Use of medications affecting glucose metabolism (e.g., benzodiazepines, thiazide diuretics, cortisone, prednisone)
  • Use of beta-adrenergic antagonists
  • Considered inappropriate for participation by the investigative team

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808-4124

Actively Recruiting

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Research Team

A

Amber Dragg

CONTACT

B

Bethany Gildersleeve

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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