Insulin and Sarcopenia in the Elderly

What Was Tested

The trial (phase 1) is built around Insulin (regular human).

It had 11 arms (groups): CMAY (active comparator), IMAY (experimental), SNPY (experimental), CSNP (active comparator) and ISNP (experimental).

Insulin in young.

L-NMMA + insulin in young.

SNP in young.

The registry classes the interventions as drug and other.

More on the Plan

Their previous studies indicate that the response of muscle proteins to the anabolic action of insulin is impaired in healthy older adults as compared to younger controls, which hampers the anabolic effect of mixed feeding on muscle proteins.

Therefore, the researchers will test in healthy subjects the following specific hypotheses: 1.

The researchers will use state-of the art stable isotope tracer techniques to measure muscle protein turnover, and a newly developed method to measure muscle perfusion in young and older subjects.

Who Took Part

Enrollment: 88 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age 18-40 yrs, and 65-85 yrs. Ability to sign consent form (score \>23 on the 30-item Mini Mental State Examination, MMSE). Stable body weight for at least 3 months.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise); pregnancy or nursing women; peripheral vascular disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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 2005-09 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): muscle protein synthesis (time frame: 5 and 8 hours).

It also tracked 1 secondary outcome, for example blood flow.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 88 people.

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.