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Unacylated Ghrelin for Peripheral Arterial Disease (GIFTII Trial)

Phase 2

Recruiting

Led By Mary McDermott, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, or 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.

Must not have

Critical limb ischemia

Wheelchair-bound or requiring a cane or walker to ambulate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months

Summary

This trial will examine whether unacylated ghrelin can improve walking ability in people with PAD compared to placebo.

Who is the study for?

This trial is for individuals aged 55 or older with peripheral artery disease (PAD), evidenced by specific diagnostic criteria. They must be able to self-administer injections and not have major liver or kidney issues, recent surgeries, or other severe health conditions that limit walking ability. Pregnant women and those unable to store the medication properly are excluded.

What is being tested?

The GIFT trial is testing whether unacylated ghrelin injections can improve walking ability in PAD patients compared to a placebo. Participants will randomly receive either the real drug or a placebo daily for four months, with their walking distance measured before and after treatment.

What are the potential side effects?

While specific side effects of unacylated ghrelin aren't detailed here, potential risks may include irritation at injection site, allergic reactions, changes in blood sugar levels, fatigue, muscle pain or weakness based on its physiological functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 years old or older.

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I have been diagnosed with peripheral artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe blockage in my leg arteries causing pain and ulcers.

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I use a wheelchair, cane, or walker to move around.

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My vision problems make it hard for me to walk.

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I am currently on a study drug or was on one in the last six months.

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My walking is limited by a condition that is not related to leg artery problems.

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I do not speak English.

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I do not have a severe illness that significantly limits my daily activities or life expectancy.

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I am not pregnant and have gone through menopause.

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I have had an amputation above or below the knee.

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My chest pain has gotten worse in the last month or I have chest pain even when resting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

4-month change in six-minute walk distance

Secondary study objectives

4-month change in calf muscle perfusion

4-month change in maximal treadmill walking time

Other study objectives

4-month change in Walking Impairment Questionnaire (WIQ) distance score

4-month change in calf muscle fiber type and size

4-month change in calf muscle succinate dehydrogenase (SDH) mitochondrial activity

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Unacylated ghrelinActive Control1 Intervention

Participants randomized to unacylated ghrelin will self-administer 20 ug/kg unacylated ghrelin daily. Study drug is dispensed in syringes labeled with the participant's name, date of birth, expiration date, and instructions for administration. Syringes will NOT be labeled with the group assignment, ensuring that both the research team collecting data and study participants are blinded to group assignment (i.e. double blinded status). Study drug is stored and handled according to the University of Chicago Research Pharmacy Standard Operating Procedure (SOP).

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to placebo will self-administer an identical-appearing solution of bacteriostatic saline daily.

0 / 12Eligibility criteria met