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Led by Pennington Biomedical Research Center · Updated on 2025-01-16
12
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effect of Pulsatile Hormone Administration on Insulin Action
C
Candida J Rebello, Ph.D.
F
Frank L Greenway, MD
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Pennington Biomedical Research Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Insulin delivered every five minutes (pulsatile) during clamp test | Insulin delivered continuously during clamp test |
|---|---|---|
| What it is | Insulin is administered in pulses every five minutes at a constant overall rate, during a highly controlled clamp procedure designed to mimic the physiological pattern of hormone release. | Insulin is administered continuously at the same average rate throughout the clamp procedure, which is the traditional experimental method for assessing insulin action. |
| Role in the trial | Tests whether a more physiological, pulsatile pattern of insulin delivery enhances insulin sensitivity compared to continuous delivery. | Acts as the experimental control to determine the baseline response to standard insulin infusion. |
| Primary use | Used only for research to investigate whether physiological hormone patterns improve insulin sensitivity in humans. | Used solely in clinical research clamp studies to serve as a baseline measure for insulin action. |
| How it is given or performed | During the clamp procedure, insulin is injected in equal amounts every five minutes, totaling 40mU/m2/min, mimicking the body’s normal hormonal fluctuations. | Insulin is infused at a steady rate of 40mU/m2/min continuously throughout the clamp test for comparison. |
| Evidence status | Research on pulsatile insulin delivery suggests that mimicking natural hormone rhythms could benefit insulin sensitivity, but conclusive clinical trial results in diverse populations are limited and not yet established for clinical use. | Continuous insulin infusion is the long-established experimental method in clamp studies to measure insulin action, with many years of research supporting its use for this specific research measurement. It is not used for routine diabetes therapy. |
| Important limitations | This delivery method is currently research-only and does not reflect real-world clinical diabetes care. Effects seen in clamp studies may not generalize to everyday settings or typical patient populations. | Because continuous infusion is used only in controlled-clamp research, findings may not predict real-life outcomes for individuals with diabetes beyond the laboratory context. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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Candida J Rebello, Tyler S Morales, Katsya Chuon...
https://pubmed.ncbi.nlm.nih.gov/37580916/Pennington Biomedical Research Center
Lead Sponsor
