Phase 2
Completed N=9
Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial
Source: ClinicalTrials.gov NCT03358355 ↗Enrolled (actual)
9
Serious AEs
5.6%
Results posted
Mar 2020
Primary outcomePrimary: Levels of Unacylated Ghrelin — 71.34; 58.01; 59.96; 845.57 pg/ml
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of Unacylated Ghrelin |
71.34; 58.01; 59.96; 845.57; 1522.36; 1102.99 | — |
| SECONDARY Brachial Artery Flow-mediated Dilation (FMD) |
0.23; 0.85; 0.06; 1.14; -2.23; 0.11 | — |
Eligibility Criteria
Inclusion Criteria
- PAD patients age 55 and older
Exclusion Criteria
- Above or below-knee amputation, critical limb ischemia, and wheelchair confinement.
- Cardiovascular event during the previous three months. [Note: Participants who have undergone coronary revascularization for a cardiac event during the previous three months may still qualify.]
- Major medical illnesses including renal disease requiring dialysis, or cancer requiring treatment in the previous year.
- Participation in another clinical trial or completion of a clinical trial in the previous month, unless they were in the control group of the previous trial.
- Unwilling to attend nine study visits over approximately six months.
- Surgery including lower extremity revascularization or orthopedic surgery in the previous month or anticipated surgery in the next three months.
- Greater than 15 mmHg difference in blood pressure in both arm pressure measurements during the ankle brachial index (ABI), diagnosis of Raynaud's phenomenon, or unable to have the blood pressure checked in both arms.
- Blood pressure < 90/50 at baseline.
- Non-English speaking, a visual impairment that limits ability to read the consent, or a hearing impairment that interferes with study participation.
- 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.
Data sourced from ClinicalTrials.gov (NCT03358355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.