Effect of Pulsatile Hormone Administration on Insulin Action

NCT06216665 | Recruiting

• 1 other identifier: PBRC 2023-018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Glucose infusion rate during the hyperinsulinemic euglycemic clamp test

  One day

Secondary Outcomes (1)

• Insulin resistance

  24 hours

Study Arms (2)

Continuous insulin at 40mU/m2/min

ACTIVE COMPARATOR

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

Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test

Pulsatile insulin at 40mU/m2/min

EXPERIMENTAL

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

Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test

Interventions

Continuous Insulin administration during hyperinsulinemic euglycemic clamp test OTHER

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

Continuous insulin at 40mU/m2/min

Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test OTHER

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

Pulsatile insulin at 40mU/m2/min

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the Motivate Study (NCT05649176)

You may not qualify if:

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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37580916 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Candida Rebello, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candida J Rebello, Ph.D.

CONTACT

225-763-3159; Candida.Rebello@pbrc.edu

Frank L Greenway, MD

CONTACT

225-763-2578; Frank.Greenway@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: March 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)