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

NCT03839511 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2021-08-19

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pennington Biomedical Research Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2019-02-08
Completion
2019-02-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03839511 on ClinicalTrials.gov