Status:
COMPLETED
Unacylated Ghrelin to Improve Functioning in PAD
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
GIFT is a pilot, randomized, double-blinded clinical trial that will examine the effects of unacylated ghrelin on walking ability in people with peripheral artery disease (PAD) compared to placebo. Pr...
Detailed Description
Work from the McDermott research team and that of other investigators shows that patients with lower extremity peripheral artery disease (PAD) have greater functional impairment, faster functional dec...
Eligibility Criteria
Inclusion
- 55 years and older
- Presence of peripheral artery disease defined as either:
- An ankle-brachial index (ABI) of less than or equal to 0.90 at the baseline study visit
- Vascular lab evidence of PAD or angiographic evidence of PAD with ischemic leg symptoms during the six-minute walk and/or treadmill exercise stress test.
Exclusion
- Above- or below-knee amputation.
- Critical limb ischemia.
- Wheelchair-bound or requiring a cane or walker to ambulate.
- Walking is limited by a symptom other than PAD.
- Current ulcer on bottom of foot. The participant may become eligible after the ulcer heals.
- Significant liver or kidney impairment defined as two or more hepatic function enzymes \> 3.0 times the upper limit of normal and/or eGFR \< 20. \[NOTE: participants who meet this criterion may undergo a re-test of hepatic function tests to determine whether initially elevated hepatic enzymes represented a transient or spurious phenomenon.\]
- Unwilling or unable to self-administer study drug.
- Failure to successfully complete the study run-in.
- Planned lower extremity revascularization or other major surgery during the next four months.
- Lower extremity revascularization, major orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months.
- Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.\]
- Mini-Mental Status Examination (MMSE) score \< 23
- Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
- Currently taking study drug(s) or has taken study drug(s) in past six months.
- Increase in angina in last month or angina at rest.
- Non-English speaking.
- Visual impairment that limits walking ability.
- Women who are pregnant or who are pre-menopausal will not be eligible.
- Potential participants who recently participated in or are currently participating in a supervised treadmill exercise and those planning to begin a supervised treadmill exercise regimen will become eligible four months after their participation in the supervised treadmill exercise program has ended.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
- The potential participant does not have adequate refrigeration for storing study drug.
- Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04377126
Start Date
July 8 2020
End Date
January 23 2025
Last Update
April 29 2025
Active Locations (2)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611-3008
2
University of Chicago
Chicago, Illinois, United States, 60637