Trial Outcomes & Findings for Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial (NCT NCT03358355)
NCT ID: NCT03358355
Last Updated: 2020-03-12
Results Overview
Levels of unacylated ghrelin are measured before and after every injection
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline and at scheduled intervals up to 24 hours after baseline
Results posted on
2020-03-12
Participant Flow
Participant milestones
| Measure |
Unacylated Ghrelin Intervention
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg
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.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial
Baseline characteristics by cohort
| Measure |
Intervention
n=9 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
|
Ankle-Brachial Index (ABI)
|
0.69 ratio
STANDARD_DEVIATION 0.13 • n=99 Participants
|
|
Body Mass Index (BMI)
|
30.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=99 Participants
|
|
Six-minute walk distance
|
1254.6 feet
STANDARD_DEVIATION 531.8 • n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and at scheduled intervals up to 24 hours after baselinePopulation: Data originate from participants that received the injection and of which had data available
Levels of unacylated ghrelin are measured before and after every injection
Outcome measures
| Measure |
Intervention(10 ug/kg)
n=5 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
n=6 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
n=4 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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
unacylated ghrelin level - Pre
|
71.34 pg/ml
Standard Deviation 58.67
|
58.01 pg/ml
Standard Deviation 29.98
|
59.96 pg/ml
Standard Deviation 31.34
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 30 min
|
845.57 pg/ml
Standard Deviation 300.12
|
1522.36 pg/ml
Standard Deviation 1339.83
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1102.99 pg/ml
Standard Deviation 595.46
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 60 min
|
772.33 pg/ml
Standard Deviation 342.00
|
1719.38 pg/ml
Standard Deviation 2012.57
|
1033.50 pg/ml
Standard Deviation 623.85
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 90 min
|
763.39 pg/ml
Standard Deviation 446.80
|
1998.58 pg/ml
Standard Deviation 3043.75
|
982.61 pg/ml
Standard Deviation 584.37
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 180 min
|
596.44 pg/ml
Standard Deviation 371.88
|
900.83 pg/ml
Standard Deviation 1078.23
|
694.51 pg/ml
Standard Deviation 389.81
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 360 min
|
373.09 pg/ml
Standard Deviation 311.77
|
492.23 pg/ml
Standard Deviation 489.99
|
410.49 pg/ml
Standard Deviation 323.12
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 720 min
|
240.94 pg/ml
Standard Deviation 135.65
|
304.62 pg/ml
Standard Deviation 294.16
|
339.46 pg/ml
Standard Deviation 295.43
|
|
Levels of Unacylated Ghrelin
unacylated ghrelin level - 1440 min
|
67.29 pg/ml
Standard Deviation 48.64
|
57.30 pg/ml
Standard Deviation 27.34
|
62.28 pg/ml
Standard Deviation 34.03
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SECONDARY outcome
Timeframe: Baseline, 6-8 hours after baseline, 24 hours after baseline.Population: Data originate from participants that received the injection and of which had data available
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.
Outcome measures
| Measure |
Intervention(10 ug/kg)
n=5 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
n=5 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
n=6 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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.
|
|---|---|---|---|
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Brachial Artery Flow-mediated Dilation (FMD)
Change in FMD 60/90 (%) from baseline to 6 hours
|
0.23 ratio
Interval -0.47 to 2.21
|
0.85 ratio
Interval 0.63 to 1.17
|
0.06 ratio
Interval -1.56 to 1.67
|
|
Brachial Artery Flow-mediated Dilation (FMD)
Change in FMD 60/90 (%) from baseline to 24-hours
|
1.14 ratio
Interval 0.99 to 1.94
|
-2.23 ratio
Interval -2.7 to -2.07
|
0.11 ratio
Interval -0.83 to 0.55
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OTHER_PRE_SPECIFIED outcome
Timeframe: Within 24 hours after subcutaneous injection.Population: Data originate from participants that received the injection and of which had data available
Adverse events
Outcome measures
| Measure |
Intervention(10 ug/kg)
n=5 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
n=6 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
n=6 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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.
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|---|---|---|---|
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Number of Participants Who Experienced Adverse Events
New swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Adverse Events
New lightheadedness or dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Adverse Events
New headaches
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Adverse Events
New symptoms
|
0 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 24 hours after subcutaneous injection.Population: Data originate from participants that received the injection and of which had data available
Serious adverse events
Outcome measures
| Measure |
Intervention(10 ug/kg)
n=9 Participants
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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.
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|---|---|---|---|
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Number of Participants Who Experienced Serious Adverse Events
|
1 Participants
|
—
|
—
|
Adverse Events
Intervention(10 ug/kg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention(20 ug/kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intervention(40 ug/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention(10 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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.
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|---|---|---|---|
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Cardiac disorders
Cardiovascular event
|
16.7%
1/6 • Number of events 1 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
Other adverse events
| Measure |
Intervention(10 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg
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.
|
Intervention(20 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg
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.
|
Intervention(40 ug/kg)
n=6 participants at risk
Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg
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.
|
|---|---|---|---|
|
General disorders
New swelling
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
|
General disorders
New lightheadedness or dizziness
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
16.7%
1/6 • Number of events 1 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
|
General disorders
New headaches
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
16.7%
1/6 • Number of events 1 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
|
General disorders
New symptoms
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
16.7%
1/6 • Number of events 1 • 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.
Participant that received any injection were monitored for adverse events.
|
0.00%
0/6 • 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.
Participant that received any injection were monitored for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place