Effect of Pulsatile Hormone Administration on Insulin Action

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT06216665
Status
Recruiting
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Conditions

  • Insulin Sensitivity

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 4, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Continuous insulin at 40mU/m2/min
    Paricipants will receive insulin infused continuously during the hyperinsulinemic euglycemic clamp test of insulin sensitivity.
  • Experimental: Pulsatile insulin at 40mU/m2/min
    Participants will receive insulin infused every five minutes during the hyperinsulinemic euglycemic clamp test of insulin sensitivity

Primary Outcome Measure

Insulin sensitivity [ Time Frame: One day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Candida Rebello, PhD
[email protected]
225-763-3159
Sara L Goff
2257630910
Frank L Greenway, PhD (SUB_INVESTIGATOR)

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Pennington Biomedical Research Center· Baton Rouge, LA

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