Evaluating a new biomarker for predicting hypoglycemia in diabetes
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.
This study is testing if a new method can help predict low blood sugar episodes in people with diabetes to improve their management and safety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT04207619 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of glial acetate metabolism as a biomarker for predicting susceptibility to insulin-induced hypoglycemia in individuals with diabetes. The approach involves using a 13C magnetic resonance spectroscopy procedure in conjunction with a hyperinsulinemic-hypoglycemic clamp procedure. By identifying individuals at risk for hypoglycemic events, the study seeks to improve diabetes management and reduce complications associated with hypoglycemia. The study builds on previous findings from a pilot study that suggested this biomarker's potential.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18-40 with a BMI between 20 and 30.
Not a fit: Patients with a history of diabetes or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of hypoglycemic events in patients with diabetes.
How similar studies have performed: Previous studies have shown promise in using biomarkers for predicting hypoglycemia, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: David McDougal, PhD — Pbrc
- Study coordinator: Amber Dragg
- Email: amber.dragg@pbrc.edu
- Phone: 225-763-3050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.