Effect of Pulsatile Hormone Administration on Insulin Action

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Insulin Sensitivity

Treatments: Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test; Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

Study type: Interventional

Funder types: Other

Identifiers

NCT06216665

PBRC 2023-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Continuous insulin at 40mU/m2/min

Active Comparator group

Description:

Paricipants will receive insulin infused continuously during the hyperinsulinemic euglycemic clamp test of insulin sensitivity.

Treatment:

Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

Pulsatile insulin at 40mU/m2/min

Experimental group

Description:

Participants will receive insulin infused every five minutes during the hyperinsulinemic euglycemic clamp test of insulin sensitivity

Treatment:

Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test