N/A
N=4
Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03839511 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Peak Epinephrine Levels — 609 pg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hyperinsulinemic-hypoglycemic clamp (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Epinephrine Levels |
609 | — |
| SECONDARY CGM Glucose |
56 | — |
Summary
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.
Eligibility 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
- 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
- Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Data sourced from ClinicalTrials.gov (NCT03839511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.