Ghrelin Dose Finding In Frail Elderly

What Was Tested

This registered phase 2 trial tested Ghrelin.

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss.

There are currently no approved therapies for frailty.

Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain.

It had two arms (groups): Ghrelin Group 1 (experimental) and Ghrelin Group 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Participants must meet all inclusion criteria and have no exclusion criteria.

Data from this portion of the study will be analyzed immediately after its completion, to allow updates to the design of the next study.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The researchers will include men and women aged 70 or older who are able to provide informed consent and are frail by the Fried criteria (Table 1). Table 1. Frailty criteria. Individuals with three, four, or all five criteria are frail. I felt that everything I did was an effort.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months; NYHA Class III or IV congestive heart failure; therapy for cancer in the past 12 months, except non-melanoma skin cancer.

How the Study Was Run

The set-up was non-randomized, parallel-group and single-blind.

The Ghrelin group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Ghrelin was given.

Those kept unaware of assignments: participant.

It started in 2012-05 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Treatment Emergent Adverse Events (time frame: 30 days following the last administration of study treatment). Median Energy Intake (time frame: 30 mins post-ghrelin or placebo). Percentage of Total Energy Intake Relative to Placebo (time frame: 30 mins post-ghrelin or placebo).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Ghrelin in 5 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Ghrelin compound page, all human trials.