Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial

What Was Tested

The trial (phase 1, phase 2) is built around Ghrelin.

It had 1 arm (groups): Intervention (experimental).

The registry classes the interventions as drug.

More on the Plan

The researchers will relate peak and Area Under the Curve values of unacylated ghrelin to brachial artery flow-mediated dilation (FMD) values.

Unacylated ghrelin levels will be measured at baseline and at defined intervals after each subcutaneous injection (30 minutes, 60 minutes, 1.5 hours, 3 hours, 6 hours, 8 to 12 hours and 24 hours).

Brachial artery FMD will be measured at baseline, before the unacylated ghrelin injection, approximately six hours, and 24 hours after each unacylated ghrelin injection.

Blood will be collected and stored for potential later analyses of circulating biomarkers, such as inflammatory biomarkers.

Who Took Part

Enrollment: 9 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

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

The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: above or below-knee amputation, critical limb ischemia, and wheelchair confinement; major medical illnesses including renal disease requiring dialysis, or cancer requiring treatment in the previous year; unwilling to attend nine study visits over approximately six months.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Ghrelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-06-07 with completion listed for 2017-08-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Levels of Unacylated Ghrelin (time frame: Baseline and at scheduled intervals up to 24 hours after baseline).

It also tracked 1 secondary outcome, for example Brachial Artery Flow-mediated Dilation (FMD).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Ghrelin in 9 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.