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

NCT03839511 | Completed Results

• 1 other identifier: 2018-050-PBRC HYPOCLAMP
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CGM Glucose

  90 minute interval following initiation of insulin infusion

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. David McDougal
• Organization: Pennington Biomedical Research Center

DAVID.MCDOUGAL@PBRC.EDU

2257630278

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: November 28, 2018
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-07

Locations

US (1)