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Myocellular Signalling in Skeletal Muscle
Plain-language guide to NCT03203317: not phased randomized trial of Insulin (regular human), 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03203317
- Phase
- not phased
- Status
- completed
- Start
- 2017-05-01
- Completion (planned or actual)
- 2017-07-26
- Participants
- 8 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Exercise; Insulin Sensitivity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Insulin (regular human).
The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men.
It had two arms (groups): Insulin-stimulation (experimental) and Exercise (experimental).
2 h insulin-clamp.
10 min of maximal exercise.
The registry classes the interventions as drug and other.
Who Took Part
8 actual participants took part.
It was open to men only aged from 18 years up to 35 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Habitual training (2-5 h/week). Lean mass 55-65 kg.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: allergy towards insulin; chronic disease.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.
Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2017-05-01 with completion listed for 2017-07-26.
It ran at 1 site in Denmark.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Change in muscle phospho-proteome signature (time frame: Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 8 people.
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, all human trials.
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.