Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
Location contact
Candida Rebello, PhD
CONTACT
Frank L Greenway, PhD
SUB_INVESTIGATOR
Sara L Goff
CONTACT
Recruiting
NCT Number: NCT06216665
Effect of Pulsatile Hormone Administration on Insulin Action
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Continuous Insulin administration during hyperinsulinemic euglycemic clamp test
OtherParticipants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test
Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
OtherParticipants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test
Primary outcomes
-
Insulin sensitivity
Time frame: One day
Glucose infusion rate during the hyperinsulinemic euglycemic clamp test
Secondary outcomes
-
Insulin resistance
Time frame: 24 hours
Homeostasis Model Assessment of Insulin Resistance
Study contacts
Contact information is provided by the study sponsor or research team.
Candida J Rebello, Ph.D.
CONTACT
Frank L Greenway, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Pennington Biomedical Research Center
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jan 22, 2024
- Registry last updated
- Jan 16, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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