Effect of Pulsatile Hormone Administration on Insulin Action
ConditionInsulin Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Completion of the Motivate Study (NCT05649176)
Disqualifiers
Non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of the Motivate study
Trial design
Design model
Crossover
Treatments tested in this trial
Continuous Insulin administration during hyperinsulinemic euglycemic clamp test
Other interventionParticipants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test
Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
Other interventionParticipants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Continuous insulin at 40mU/m2/minActive comparator 1 intervention
Group B: Pulsatile insulin at 40mU/m2/minExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insulin sensitivity
Glucose infusion rate during the hyperinsulinemic euglycemic clamp test
Time frame
One daySecondary outcomes
1
Insulin resistance
Homeostasis Model Assessment of Insulin Resistance
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov