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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperinsulinemic-hypoglycemic clamp

Procedure

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.

Primary outcomes

Peak Epinephrine Levels

Time frame: 90 minute interval following initiation of insulin infusion

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

Secondary outcomes

CGM Glucose

Time frame: 90 minute interval following initiation of insulin infusion

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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 15, 2019
Registry last updated: Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed