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

Pennington Biomedical Research Center4 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes

Interventions

Hyperinsulinemic-hypoglycemic clampPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Peak Epinephrine Levels

This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure

Time frame: 90 minute interval following initiation of insulin infusion

Secondary Outcomes

CGM Glucose

This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure