Effect of Pulsatile Hormone Administration on Insulin Action

Not Applicable

Recruiting

• Conditions: Insulin Sensitivity
• Interventions: Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test; Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

• Registration Number: NCT06216665
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Status Verified: 2024-03
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Completion of the Motivate Study (NCT05649176)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous insulin at 40mU/m2/min	Continuous Insulin administration during hyperinsulinemic euglycemic clamp test	Paricipants will receive insulin infused continuously during the hyperinsulinemic euglycemic clamp test of insulin sensitivity.
Pulsatile insulin at 40mU/m2/min	Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test	Participants will receive insulin infused every five minutes during the hyperinsulinemic euglycemic clamp test of insulin sensitivity

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	One day	Glucose infusion rate during the hyperinsulinemic euglycemic clamp test

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	24 hours	Homeostasis Model Assessment of Insulin Resistance

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States