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Effect of Pulsatile Hormone Administration on Insulin Action

Effect of Pulsatile Hormone Administration on Insulin Action

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06216665
Enrollment
4
Registered
2024-01-22
Start date
2024-03-04
Completion date
2024-05-09
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Sensitivity

Brief 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.

Detailed 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.

Interventions

OTHERContinuous Insulin administration during hyperinsulinemic euglycemic clamp test

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

OTHERPulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

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

Sponsors

Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivityOne dayGlucose infusion rate during the hyperinsulinemic euglycemic clamp test

Secondary

MeasureTime frameDescription
Insulin resistance24 hoursHomeostasis Model Assessment of Insulin Resistance

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCandida Rebello, PhD

Pennington Biomedical Research Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026