Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study

Study Overview
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Brief Summary
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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.

Official Title
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Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study

Conditions
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Diabetes

Intervention / Treatment
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* Procedure: Hyperinsulinemic-hypoglycemic clamp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hyperinsulinemic-hypoglycemic clamp|Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Epinephrine Levels | This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure | 90 minute interval following initiation of insulin infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM Glucose | This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure | 90 minute interval following initiation of insulin infusion |