Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
ID06216665

Effect of Pulsatile Hormone Administration on Insulin Action

Led by Pennington Biomedical Research Center · Updated on 2025-01-16

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates insulin sensitivity in people with obesity and insulin resistance by comparing two methods of insulin infusion during the hyperinsulinemic euglycemic clamp test. The study aims to understand how delivering insulin in pulses versus continuously affects insulin action, which helps control blood sugar levels. The trial is a controlled, non-randomized, two-arm study involving participants who have completed a previous related study called Motivate. Participants will undergo two clamp tests within a week. In the first test, insulin is infused continuously at a set dose. In the second, the same total insulin dose is given in pulses every five minutes. Following these tests, participants will return after fasting for blood samples to measure glucose and insulin levels. Throughout the study, researchers will monitor insulin sensitivity primarily, with insulin resistance as a secondary measure. The total participation involves returning for two clamp tests and a fasting blood draw, all occurring within a short timeframe. The study does not use masking or placebos and is led by the Pennington Biomedical Research Center.

CONDITIONS

Brief Title

Effect of Pulsatile Hormone Administration on Insulin Action

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Completion of the Motivate Study (NCT05649176)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Intervention

Duration - Within 1 week

Participants complete two hyperinsulinemic euglycemic clamp tests to receive insulin either continuously or in pulses every five minutes.

2 visits for clamp tests within a week

Follow-up

Duration - 1 day

Participants return the day after the clamp tests in a fasted state for blood draws to measure glucose and insulin.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

C

Candida J Rebello, Ph.D.

F

Frank L Greenway, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action.

Candida J Rebello, Tyler S Morales, Katsya Chuon...

https://pubmed.ncbi.nlm.nih.gov/37580916