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

July 25, 2021 updated by: David McDougal, Pennington Biomedical Research Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808-4124
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will enroll up to 8 healthy men or women (goal n=3 completers) in this method development study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 minute interval following initiation of insulin infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 minute interval following initiation of insulin infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2018

Primary Completion (ACTUAL)

February 8, 2019

Study Completion (ACTUAL)

February 8, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-050-PBRC HYPOCLAMP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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