Unacylated Ghrelin to Improve Functioning in PAD

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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. Preliminary evidence suggests that unacylated ghrelin may improve blood flow to the extremities and promote improved skeletal muscle growth and energy use.

A total of 30 participants with PAD will be randomized to one of two groups: unacylated ghrelin injections or placebo injections . Participants will self-administer the study drug or placebo subcutaneously once daily for four months. The primary outcome is change in six-minute walk distance between baseline and 4-month follow-up

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Institute on Aging (NIA)

Criteria

Inclusion Criteria:

1. 55 years and older

2. Presence of peripheral artery disease

• Defined as an ankle-brachial index (ABI) of less than or equal to 0.90 at the baseline study visit

Exclusion Criteria:

1. Above- or below-knee amputation.

2. Critical limb ischemia.

3. Wheelchair-bound or requiring a cane or walker to ambulate.

4. Walking is limited by a symptom other than PAD.

5. Current ulcer on bottom of foot. The participant may become eligible after the ulcer heals.

6. 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.]

7. Unwilling or unable to self-administer study drug.

8. Failure to successfully complete the study run-in.

9. Planned lower extremity revascularization or other major surgery during the next four months.

10. Lower extremity revascularization, major orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months.

11. 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.]

12. Mini-Mental Status Examination (MMSE) score < 23

13. 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.]

14. Currently taking study drug(s) or has taken study drug(s) in past six months.

15. Increase in angina in last month or angina at rest.

16. Non-English speaking.

17. Visual impairment that limits walking ability.

18. Women who are pregnant or who are pre-menopausal will not be eligible.

19. 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.

20. 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.

21. 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.