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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839511
• Other study ID #: 2018-050-PBRC HYPOCLAMP
• Status: Completed
• Start date: November 28, 2018
• Est. completion date: February 8, 2019

Study information

• Verified date: July 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Hypoglycemia

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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