RECRUITING

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-19
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04207619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy male or female
  2. * Ages 18-40 years
  3. * BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
  4. * Medically cleared for participation in the study
  1. * Contraindication to MRI
  2. * Consume \>10 alcoholic drinks/week
  3. * History of chronic smoking or have quit less than 10 years ago
  4. * History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
  5. * Average screening blood pressure \>140/90 mmHg
  6. * History of cardiovascular disease
  7. * Pregnant, planning to become pregnant, or breastfeeding
  8. * Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
  9. * Use of beta-adrenergic antagonists.
  10. * Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.

Contacts and Locations

Study Contact

Amber Dragg
CONTACT
225-763-3050
amber.dragg@pbrc.edu
Bethany Gildersleeve
CONTACT
225-763-2709
Bethany.Gildersleeve@pbrc.edu

Principal Investigator

David McDougal, PhD
PRINCIPAL_INVESTIGATOR
PBRC

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • David McDougal, PhD, PRINCIPAL_INVESTIGATOR, PBRC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-19
Study Completion Date2025-09

Study Record Updates

Study Start Date2020-02-19
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes
  • Hypoglycemia