NCT03358355

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 12, 2020

Completed
Last Updated

March 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

June 19, 2017

Results QC Date

March 28, 2019

Last Update Submit

February 26, 2020

Conditions

Peripheral Artery DiseasePADPeripheral Arterial Disease

Keywords

PADunacylated ghrelinPeripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Levels of Unacylated Ghrelin

    Levels of unacylated ghrelin are measured before and after every injection

    Baseline and at scheduled intervals up to 24 hours after baseline

Secondary Outcomes (1)

  • Brachial Artery Flow-mediated Dilation (FMD)

    Baseline, 6-8 hours after baseline, 24 hours after baseline.

Other Outcomes (2)

  • Number of Participants Who Experienced Adverse Events

    Within 24 hours after subcutaneous injection.

  • Number of Participants Who Experienced Serious Adverse Events

    Within 24 hours after subcutaneous injection.

Study Arms (1)

Intervention

EXPERIMENTAL

Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg

Drug: unacelyated ghrelin

Interventions

unacelyated ghrelinDRUG

We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant.

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. PAD patients age 55 and older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Mary McDermott MD
Organization
Northwestern University
mdm608@northwestern.edu
312-503-6419

Study Officials

  • Mary McDermott, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jeremiah Stamler Professor

Study Record Dates

First Submitted

June 19, 2017

First Posted

November 30, 2017

Study Start

June 7, 2016

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

March 12, 2020

Results First Posted

March 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)