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NCT Number: NCT04207619

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 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location status: Recruiting

Location contact

Department of Recruiting

CONTACT

[email protected]

225-763-3000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Average screening blood pressure >140/90 mmHg
  • History of cardiovascular disease
  • Pregnant, planning to become pregnant, or breastfeeding
  • Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
  • Use of beta-adrenergic antagonists.
  • Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.

Treatment and study plan

hyperinsulinemic-hypoglycemic clamp

Other

An intravenous catheter will be placed in an antecubital vein for infusion of insulin and glucose. A second catheter will be placed retrograde in a dorsal vein of the contra-lateral hand for blood withdrawal. The hand will be placed in a heating box or pad at 70°C for arterialization of venous blood. A primed infusion of regular insulin (120 mU/min/m2) will be initiated and continued for approximately 2 hours. Beginning 20 minutes prior to the start of the insulin infusion, arterialized venous blood glucose will be measured at 5 minute intervals via a Hemocue or YSI analyzer. Following initiation of insulin infusion, blood glucose will be allowed to fall to 50 mg/dL and then maintained at this level using a variable infusion of exogenous dextrose (20% solution). Our goal is to achieve steady-state (blood glucose stabilized at 50 +/- 5 mg/dL) within the first 45 minutes following the start of insulin infusion.

13C-MRS procedure/Acetate infusion

Other

Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples

Primary outcomes

  1. Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)

    Time frame: Every ten minutes for 120 minutes following administration of 1-13C acetate

    Glial acetate metabolism

Secondary outcomes

  1. Change in serum epinephrine levels

    Time frame: epinephrine will be measured every 15 minutes for 135 minutes.

    The change is serum epinephrine during the hypoglycemic clamp will be determined relative to baseline levels

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Dragg

CONTACT

[email protected]

225-763-3050

Bethany Gildersleeve

CONTACT

[email protected]

225-763-2709

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.

Acronym: E-VAL

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2019
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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