← Back to Search

Biomarker Evaluation for Low Blood Sugar (E-VAL Trial)

N/A
Recruiting
Led By David McDougal, PhD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male or female
Ages 18-40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every ten minutes for 120 minutes following administration of 1-13c acetate
Awards & highlights

E-VAL Trial Summary

This trial is testing a potential biomarker for predicting susceptibility to hypoglycemia in people with diabetes, which could significantly improve treatment.

Who is the study for?
This trial is for healthy men and women aged 18-40 with a BMI of 20-30 kg/m2. Participants must be medically cleared to join, not pregnant or breastfeeding, consume less than 10 alcoholic drinks per week, have no MRI contraindications, no cardiovascular disease history, normal blood pressure and glucose levels, non-smokers or those who quit over 10 years ago.Check my eligibility
What is being tested?
The study tests if glial acetate metabolism can predict low blood sugar events in diabetics. It uses a special brain scan (13C-MRS) after an acetate infusion and compares it to the body's response during controlled insulin-induced hypoglycemia using a hyperinsulinemic-hypoglycemic clamp procedure.See study design
What are the potential side effects?
Potential side effects may include discomfort from the MRS procedure or reactions to the acetate infusion such as nausea. The clamp procedure might cause symptoms related to low blood sugar like dizziness, sweating, hunger, irritability or confusion.

E-VAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy individual.
Select...
I am between 18 and 40 years old.

E-VAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every ten minutes for 120 minutes following administration of 1-13c acetate
This trial's timeline: 3 weeks for screening, Varies for treatment, and every ten minutes for 120 minutes following administration of 1-13c acetate for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Secondary outcome measures
Change in serum epinephrine levels

E-VAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
Participants will have their glial acetate metabolism measured by carbon-13 magnetic resonance spectroscopy as well as their neuroendocrine response to hypoglycemia 3 days later.

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
304 Previous Clinical Trials
181,426 Total Patients Enrolled
David McDougal, PhD4.137 ReviewsPrincipal Investigator - PBRC
Pennington Biomedical Research Center
1 Previous Clinical Trials
6 Total Patients Enrolled
5Patient Review
Dr. MacDougall was considerate of my wishes to try conservative measures, such as physical therapy, before resorting to surgery. He was also very thorough in his explanation of my MRI results. I appreciated his Wisdom and compassion.

Media Library

hyperinsulinemic-hypoglycemic clamp Clinical Trial Eligibility Overview. Trial Name: NCT04207619 — N/A
Low Blood Sugar Research Study Groups: Arm 1
Low Blood Sugar Clinical Trial 2023: hyperinsulinemic-hypoglycemic clamp Highlights & Side Effects. Trial Name: NCT04207619 — N/A
hyperinsulinemic-hypoglycemic clamp 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207619 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room for further participants in this clinical investigation?

"Indeed, the clinicaltrials.gov website shows that this experiment is in current need of participants. It was initially unveiled on February 19th 2020 and adjusted most recently on August 29th 2022. The trial necessitates 10 volunteers from a single medical centre."

Answered by AI

How many participants has this medical trial recruited thus far?

"Affirmative. Clinicaltrials.gov reveals that this trial, first launched on February 19th 2020, is still actively recruiting participants. To date, 10 patients are needed and the research is being conducted at a single site."

Answered by AI

Are younger individuals within the age range of this clinical trial's eligibility criteria?

"The parameters set forth for participation in the trial draw a line at 18 years old on one side and 40 on the other, making those within this age range suitable to join."

Answered by AI

Is it possible to join the research protocol?

"This clinical investigation is recruiting 10 participants with hypoglycemia aged between 18 and 40. The ideal candidate must exhibit the following attributes: Male or female, within the age range of 18-40 years old, BMI between 20 kg/m2 to 30 kg/m2 (with an accepted variance of 0.5kg/m2), Medically cleared for participation in this trial."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Pennington Biomedical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation
David McDougal 2020. "Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04207619.
All > Hypoglycemia
~0 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top