Effect of Pulsatile Hormone Administration on Insulin Action

NCT ID: NCT06216665

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-12-31

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.

Conditions

Insulin Sensitivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Continuous insulin at 40mU/m2/min

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

Group Type: ACTIVE_COMPARATOR

Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

Intervention Type: OTHER

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

Pulsatile insulin at 40mU/m2/min

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

Group Type: EXPERIMENTAL

Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

Intervention Type: OTHER

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

Interventions

Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

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

Intervention Type: OTHER

Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Candida Rebello

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candida Rebello, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Candida J Rebello, Ph.D.

Role: CONTACT

Candida.Rebello@pbrc.edu

225-763-3159

Frank L Greenway, MD

Role: CONTACT

Frank.Greenway@pbrc.edu

225-763-2578

Facility Contacts

Candida Rebello, PhD

Role: primary

Candida.Rebello@pbrc.edu

225-763-3159

Sara L Goff

Role: backup

2257630910

References

Rebello CJ, Morales TS, Chuon K, Dong S, Lam VT, Purner D, Lewis S, Lakey J, Beyl RA, Greenway FL. Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action. Obes Rev. 2023 Dec;24(12):e13625. doi: 10.1111/obr.13625. Epub 2023 Aug 14.

Reference Type: BACKGROUND

PMID: 37580916 (View on PubMed)

Other Identifiers

PBRC 2023-018

Identifier Type: -

Identifier Source: org_study_id