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

Completed

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT03839511

Run by

Pennington Biomedical Research Center

People needed

4

Starts

2018-11-28

Expected to finish

2019-02-08

Last updated by the study team

2021-08-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.