Peripheral Arterial Disease Clinical Trial
Official title:
Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial
The GIFT pilot study will investigate the optimal subcutaneous dose and safety of subcutaneously administered unacylated ghrelin in older people with peripheral artery disease (PAD).
The pilot GIFT Trial will obtain preliminary evidence to identify the optimal dose of
subcutaneously administered unacylated ghrelin in people with PAD. The results of this pilot
study may be used to design a randomized trial of unacylated ghrelin, in subsequent study, to
improve functioning and prevent mobility loss in older people with PAD.
In our primary specific aims, we will 1) establish the association of increasing doses of
subcutaneous unacylated ghrelin with circulating levels of unacylated ghrelin 2) assess the
safety of increasing doses of subcutaneously administered unacylated ghrelin in six patients
with PAD age 55 and older. We will relate peak and Area Under the Curve values of unacylated
ghrelin to brachial artery flow-mediated dilation (FMD) values. To achieve these aims, six
PAD participants age 55 and older will receive a single subcutaneous injection of unacylated
ghrelin at doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg, respectively, on three separate days at
least one week apart. 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.
This is a Phase I study to guide dose finding for a pilot study of unacylated ghrelin in
people with PAD.
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