A Phase 1/2 interventional study of unacelyated ghrelin in Peripheral Artery Disease, PAD and Peripheral Arterial Disease, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Northwestern University · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg
Drug: unacelyated ghrelin
We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant.
Levels of Unacylated Ghrelin
Levels of unacylated ghrelin are measured before and after every injection
Time frame: Baseline and at scheduled intervals up to 24 hours after baseline
Brachial Artery Flow-mediated Dilation (FMD)
Brachial artery flow-mediated dilation in response to hyperemia. The outcome is reporting the MAX Relative FMD 60/90 (%), which is calculated as the highest FMD between the RH60 and RH90 results, as a percent.
Time frame: Baseline, 6-8 hours after baseline, 24 hours after baseline.
Number of Participants Who Experienced Adverse Events
Adverse events
Time frame: Within 24 hours after subcutaneous injection.
Number of Participants Who Experienced Serious Adverse Events
Serious adverse events
Time frame: Within 24 hours after subcutaneous injection.
| Milestone | Unacylated Ghrelin Intervention |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
Levels of unacylated ghrelin are measured before and after every injection
| pg/ml | Intervention(10 ug/kg) | Intervention(20 ug/kg) | Intervention(40 ug/kg) |
|---|---|---|---|
| unacylated ghrelin level - Pre | 71.34 ± 58.67 | 58.01 ± 29.98 | 59.96 ± 31.34 |
| unacylated ghrelin level - 30 min | 845.57 ± 300.12 | 1522.36 ± 1339.83 | 1102.99 ± 595.46 |
| unacylated ghrelin level - 60 min | 772.33 ± 342.00 | 1719.38 ± 2012.57 | 1033.50 ± 623.85 |
| unacylated ghrelin level - 90 min | 763.39 ± 446.80 | 1998.58 ± 3043.75 | 982.61 ± 584.37 |
| unacylated ghrelin level - 180 min | 596.44 ± 371.88 | 900.83 ± 1078.23 | 694.51 ± 389.81 |
| unacylated ghrelin level - 360 min | 373.09 ± 311.77 | 492.23 ± 489.99 | 410.49 ± 323.12 |
| unacylated ghrelin level - 720 min | 240.94 ± 135.65 | 304.62 ± 294.16 | 339.46 ± 295.43 |
| unacylated ghrelin level - 1440 min | 67.29 ± 48.64 | 57.30 ± 27.34 | 62.28 ± 34.03 |
Brachial artery flow-mediated dilation in response to hyperemia. The outcome is reporting the MAX Relative FMD 60/90 (%), which is calculated as the highest FMD between the RH60 and RH90 results, as a percent.
| ratio | Intervention(10 ug/kg) | Intervention(20 ug/kg) | Intervention(40 ug/kg) |
|---|---|---|---|
| Change in FMD 60/90 (%) from baseline to 6 hours | 0.23 (-0.47 to 2.21) | 0.85 (0.63 to 1.17) | 0.06 (-1.56 to 1.67) |
| Change in FMD 60/90 (%) from baseline to 24-hours | 1.14 (0.99 to 1.94) | -2.23 (-2.70 to -2.07) | 0.11 (-0.83 to 0.55) |
Adverse events
| Participants | Intervention(10 ug/kg) | Intervention(20 ug/kg) | Intervention(40 ug/kg) |
|---|---|---|---|
| New swelling | 0 | 0 | 0 |
| New lightheadedness or dizziness | 0 | 1 | 0 |
| New headaches | 0 | 1 | 0 |
| New symptoms | 0 | 1 | 0 |
Serious adverse events
| Participants | Intervention |
|---|---|
| Number of Participants Who Experienced Serious Adverse Events | 1 |
Collected over Adverse events will be monitored continuously throughout the study and will be reported to the DSMB and IRB in a timely manner according to pre-specified requirements. We will minimize risk by observing study participants for approximately 8-12 hours after each of the three doses of unacylated ghrelin.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention(10 ug/kg) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) |
| Intervention(20 ug/kg) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Intervention(40 ug/kg) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | Intervention(10 ug/kg) | Intervention(20 ug/kg) | Intervention(40 ug/kg) |
|---|---|---|---|
| Cardiovascular eventCardiac disorders | 1/6 | 0/6 | 0/6 |
| Event | Intervention(10 ug/kg) | Intervention(20 ug/kg) | Intervention(40 ug/kg) |
|---|---|---|---|
| New lightheadedness or dizzinessGeneral disorders | 0/6 | 1/6 | 0/6 |
| New headachesGeneral disorders | 0/6 | 1/6 | 0/6 |
| New symptomsGeneral disorders | 0/6 | 1/6 | 0/6 |
| New swellingGeneral disorders | 0/6 | 0/6 | 0/6 |
| Age, Categorical(Participants) | Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 9 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 71.0 ± 4.7 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 1 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Intervention |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 9 |
| Ankle-Brachial Index (ABI)(ratio) | Intervention |
|---|---|
| Mean | 0.69 ± 0.13 |
| Body Mass Index (BMI)(kg/m^2) | Intervention |
|---|---|
| Mean | 30.4 ± 4.6 |
1 further baseline measures are reported on the registry.
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