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Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Plain-language guide to NCT05244694: early phase 1 interventional trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05244694
- Phase
- early phase 1
- Status
- completed
- Start
- 2020-08-06
- Completion (planned or actual)
- 2021-06-25
- Participants
- 28 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Vasoconstriction; Healthy; Insulin Resistance
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered early phase 1 trial tested Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.
It had 1 arm (groups): Insulin (experimental).
Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.
The registry classes the interventions as drug.
Who Took Part
28 actual participants took part.
It was open to people of any sex aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy adult men and women;. 18-45 years of age;. BMI 18-30 kg/m2;.
The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions; hepatic, renal, pulmonary, cardiovascular, or neurological disease;; stroke or neurovascular disease;.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Insulin (regular human) study: the insulin resistance, prediabetes & type 2 diabetes participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2020-08-06 with completion listed for 2021-06-25.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Amount of leg blood flow (time frame: Change from baseline at minute 60).
It also tracked 2 secondary outcomes, for example Amount of muscle sympathetic nerve activity (MSNA) and Amount of cerebral blood flow.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Insulin (regular human) in 28 people with insulin resistance, prediabetes & type 2 diabetes.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.