Effect of Pulsatile Hormone Administration on Insulin Action

Last updated: January 14, 2025
Sponsor: Pennington Biomedical Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Hormone Deficiencies

Stress

Treatment

Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

Clinical Study ID

NCT06216665
PBRC 2023-018
  • Ages 50-75
  • All Genders

Study Summary

In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. Given the fluctuations in insulin concentrations, oscillations enhance precision of control. The hyperinsulinemic euglycemic clamp test (clamp) involves a continuous infusion of insulin and is the gold standard for measuring insulin sensitivity. In this study, insulin sensitivity measured using the standard clamp will be compared with a clamp in which the same total amount of insulin as the standard clamp is infused every five minutes instead of continuously.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of the Motivate Study (NCT05649176)

Exclusion

Exclusion Criteria:

  • Non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of theMotivate study

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test
Phase:
Study Start date:
March 04, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Participants with obesity and insulin resistance completing a randomized, controlled, two-arm parallel trial (Motivate) will be enrolled in this cross-sectional study. Twelve participants from the Motivate study will return within two weeks to complete two clamp tests within a week of each other. At these clamps, the insulin will be infused continuously at a dose of 40mU/m2/min during the first clamp test and the same total amount of insulin will be infused every five minutes at the second clamp. The day following the clamps, participants will return to the clinic in a fasted state and blood will be drawn for measurement of glucose and insulin.

Connect with a study center

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.