← Back to Search

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months

Awards & highlights

GIFTII Trial 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.Check my eligibility

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.See study design

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.

GIFTII Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 55 years old or older.

Select...

I have been diagnosed with peripheral artery disease.

GIFTII Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

4-month change in six-minute walk distance

Secondary outcome measures

4-month change in calf muscle perfusion

4-month change in maximal treadmill walking time

Other outcome measures

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

GIFTII 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,221 Total Patients Enrolled

24 Trials studying Peripheral Arterial Disease

4,392 Patients Enrolled for Peripheral Arterial Disease

National Institute on Aging (NIA)NIH

1,672 Previous Clinical Trials

28,018,633 Total Patients Enrolled

20 Trials studying Peripheral Arterial Disease

16,565 Patients Enrolled for Peripheral Arterial Disease

Mary McDermott, MD5.01 ReviewsPrincipal Investigator - Northwestern University

Northwestern University

11 Previous Clinical Trials

1,854 Total Patients Enrolled

11 Trials studying Peripheral Arterial Disease

1,854 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this clinical trial?

"Clinicaltrials.gov indicates that this trial is actively seeking participants, with the original posting date of July 8th 2020 and a recent update on November 13th 2022."

Answered by AI

Has Unacylated ghrelin received sanctioning from the FDA?

"Taking into account the Phase 2 status of this medication, which evidences safety but no efficacy data yet, our team at Power assigned unacylated ghrelin a score of 2 on their scale."

Answered by AI

Is there a body of research on the effects of Unacylated ghrelin?

"Currently, two scientific investigations are in progress to ascertain the efficacy of unacylated ghrelin. Neither is at Phase 3 yet; however there are three different trial sites located in Cincinnati, Ohio."

Answered by AI

What is the current enrollment capacity for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting participants and has been since July 8th 2020; the protocol was last updated on November 13th 2022. The study seeks 30 patients from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Unacylated Ghrelin to Improve Functioning in PAD

Mary McDermott 2020. "Unacylated Ghrelin to Improve Functioning in PAD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04377126.

All > Pad