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Completed

NCT Number: NCT06216665

Effect of Pulsatile Hormone Administration on Insulin Action

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.

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Key information

Conditions

Insulin Sensitivity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of the Motivate Study (NCT05649176)

Exclusion criteria

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

Treatment and study plan

Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

Other

Participants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test

Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

Other

Participants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test

Primary outcomes

  1. Insulin sensitivity

    Time frame: One day

    Glucose infusion rate during the hyperinsulinemic euglycemic clamp test

Secondary outcomes

  1. Insulin resistance

    Time frame: 24 hours

    Homeostasis Model Assessment of Insulin Resistance

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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