Effect of Pulsatile Hormone Administration on Insulin Action
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test, Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test.
- Who it may be relevant to
- Registry conditions: Insulin Sensitivity. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Continuous Insulin administration during hyperinsulinemic euglycemic clamp test
Participants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test - Other Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
Participants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test
Primary outcome measures
- Insulin sensitivity [Time frame: One day]
Secondary outcome measures (1)
- Insulin resistance [Time frame: 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Publications
- 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
Identifiers
NCT: NCT06216665 · PBRC 2023-018