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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

Must not have

History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL

Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every ten minutes for 120 minutes following administration of 1-13c acetate

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy individual.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes or my fasting blood sugar is over 126 mg/dL.

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I am taking medication that can affect my blood sugar levels.

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I have a history of heart disease.

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I am taking beta-blockers.

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I have smoked for many years or quit smoking less than 10 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every ten minutes for 120 minutes following administration of 1-13c acetate

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in serum epinephrine levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

309 Previous Clinical Trials

179,908 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.