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Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Plain-language guide to NCT05153395: early phase 1 non-randomized trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 65 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05153395
- Phase
- early phase 1
- Status
- suspended
- Start
- 2021-12-01
- Completion (planned or actual)
- 2027-06
- Participants
- 65 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Healthy; Vasodilation; Insulin Resistance; Autonomic Dysfunction; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.
It had three arms (groups): Insulin (Doppler) (experimental), Insulin (MRI) (experimental) and Time Control (Doppler) (other).
Time control only.
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 65 planned participants were the target.
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 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; hepatic, renal, pulmonary, cardiovascular, or neurological disease;; stroke or neurovascular disease;.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.
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.
It started in 2021-12-01 with completion listed for 2027-06.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Amount of cerebral blood flow (time frame: Change from baseline at minute 15).
It also tracked 2 secondary outcomes, for example Amount of muscle sympathetic nerve activity (MSNA) and Amount of leg blood flow.
What This Means in Plain Language
Put simply, this is a early phase 1, non-randomized trial of Insulin (regular human) in 65 people with insulin resistance, prediabetes & type 2 diabetes.
Its status is suspended; 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.