Effect of Pulsatile Hormone Administration on Insulin Action

Insulin Sensitivity Clinical Trial

Official title:

Effect of Pulsatile Hormone Administration on Insulin Action

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216665
• Other study ID #: PBRC 2023-018
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Pennington Biomedical Research Center
• Contact: Candida J Rebello, Ph.D.
• Phone: 225-763-3159
• Email: Candida.Rebello[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Other:
• Continuous Insulin administration during hyperinsulinemic euglycemic clamp test
Participants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test
• Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
Participants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Glucose infusion rate during the hyperinsulinemic euglycemic clamp test	One day
Secondary	Insulin resistance	Homeostasis Model Assessment of Insulin Resistance	24 hours