mTOR as Mediator of Insulin Sensitivity Study

What Was Tested

This registered not phased trial tested Insulin (regular human).

The study investigates the role of mTOR in mediating enhancement of muscle insulin sensitivity following a single bout of exercise.

It had two arms (groups): Post-exercise insulin sensitivity following placebo administration (placebo comparator) and Post-exercise insulin sensitivity following Rapamycin administration (experimental).

Young healthy males will ingest placebo (blinded) and perform a single bout of knee-extensor exercise and insulin action is investigated 4 hours after cessation of exercise. Insulin action towards muscle glucose uptake and protein synthesis will be investigated during a 120 min euglycemic hyperinsulinemic clamp.

Young healthy males will ingest Rapamycin (blinded) and perform a single bout of knee-extensor exercise and insulin action is investigated 4 hours after cessation of exercise. Insulin action towards muscle glucose uptake and protein synthesis will be investigated during a 120 min euglycemic hyperinsulinemic clamp.

The registry classes the interventions as drug, other and procedure.

More on the Plan

It is requested that the study subject will arrive in a car or with public transportation.

Pulmonary oxygen uptake is measured with the use of an online system before, during and after exercise and is used for determination of substrate metabolism.

Blood samples from the femoral veins in both legs and the femoral artery in one of the legs are drawn before, during exercise, and during the recovery period after exercise.

At the same time blood flow is measured in the femoral arteries in both legs with the use of Doppler technique.

Who Took Part

10 planned participants were the target.

It was open to men only aged from 22 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: No use of medications. Age 22-35 years. BMI between 18.0 and 25.0.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: physical activity (e.g., running, cycling, fitness, etc.) above 6 hours a week; acute sickness less than 2 weeks prior to study start; if disease appears or is identified and/or a need for medication arises after inclusion but before initiation of the study.

How the Study Was Run

Design: non-randomized, crossover and double-blind.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2022-02-10 with completion listed for 2029-06.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Insulin stimulated muscle glucose uptake (time frame: Through study completion, approx. 1 year).

It also tracked 2 secondary outcomes, for example Insulin stimulated muscle protein synthesis and Posttranslational modification of proteins in muscle biopsies.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) in 10 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.