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

Completed

• Conditions: Diabetes

• Registration Number: NCT03839511
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-28
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Results First Submitted: 2021-06-28
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-25
• Last Update Submitted: 2021-07-25
• Results First Posted: 2021-08-19
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Epinephrine Levels	90 minute interval following initiation of insulin infusion	This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure

Secondary Outcome Measures

Name	Time	Method
CGM Glucose	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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States