- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054519
Improve PAD PERformance With METformin (PERMET)
May 22, 2023 updated by: Mary McDermott, Northwestern University
Improve PAD Performance With Metformin: The PERMET Trial
The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
212
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathryn Domanchuk, BS
- Phone Number: 312-503-6438
- Email: k-domanchuk@northwestern.edu
Study Contact Backup
- Name: Mary McDermott, MD
- Phone Number: 312-503-6419
- Email: mdm608@northwestern.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Completed
- University of Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Principal Investigator:
- Tamar Polonsky, MD
-
Contact:
- Tamar Polonsky, MD
- Phone Number: 312-608-0250
- Email: tpolonsky@bsd.uchicago.edu
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Mary McDermott, MD
- Phone Number: 312-503-6419
- Email: mdm608@northwestern.edu
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Completed
- Ochsner Medical Center
-
New Orleans, Louisiana, United States, 70112
- Completed
- Tulane University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows:
- First, an ankle brachial index (ABI) <=0.90 at the baseline study visit is an inclusion criterion for PAD.
- Second, potential participants who have an ABI > 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible.
- Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible.
- Fourth, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI > 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.
Exclusion Criteria:
- Above- or below-knee amputation.
- Critical limb ischemia.
- Wheelchair-bound or requiring a walker to ambulate.
- Walking is limited by a symptom other than PAD.
- Current foot ulcer on bottom of foot.
- Diabetes mellitus defined as one or more of a) patient report of physician diagnosed diabetes mellitus, b) use of one or more diabetes medications, c) two baseline hemoglobinA1C values of >6.5, d) two fasting glucose values >126 mg/dl. [NOTE: the second fasting glucose value and hemoglobin A1C values will be at the discretion of the principal investigator. For example, if the first glucose value is >300 or the first A1C value is >6.9, then investigators may decide not to repeat the value.]
- Chronic kidney disease defined as GFR <=45. [NOTE: if GFR is 40-44, investigator discretion will be used to determine if a repeat test may be performed. If the second GFR value is >45, the participant may be included.]
- Chronic liver disease defined as two or more hepatic function tests >=2.0 times the upper limit of normal. [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.]
- Failure to successfully complete the 2-week study run-in, defined as unable to tolerate metformin and/or failing to take the medication daily for 10 or more days in the two-week period.
- Planned lower extremity revascularization, orthopedic surgery, or other major surgery during the next six months.
- Lower extremity revascularization, orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months.
- 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.]
- Mini-Mental Status Examination (MMSE) score <23 or dementia. However, investigator discretion may be used to allow some people below this threshold to participate, if the investigator determines there is another reason for their lower score, including lack of familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher. Note that the MMSE include some spelling and English writing proficiency.
- 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.]
- Currently taking metformin or has taken metformin in past six months.
- Increase in angina or angina at rest
- Non-English speaking.
- Visual impairment that limits walking ability.
- 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.
Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metformin
Metformin daily
|
Participants will be prescribed up to 2,000 mgs daily of metformin
|
Placebo Comparator: Placebo
Placebo daily for six months.
|
Placebo pills will appear identical to the metformin to maintain blinding of participants and investigators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six-minute walk performance
Time Frame: Change from baseline to six-month follow-up
|
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol.
The goal is for them to walk as far as possible in six minutes
|
Change from baseline to six-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calf muscle biopsy biochemical measures
Time Frame: Change from baseline to six-month follow-up
|
A skeletal muscle sample will be obtained from the gastrocnemius muscle.
|
Change from baseline to six-month follow-up
|
Maximal treadmill walking time
Time Frame: Change from baseline to six-month follow-up
|
A Gardner treadmill exercise protocol will be used
|
Change from baseline to six-month follow-up
|
Brachial artery flow-mediated dilation
Time Frame: Change from baseline to six-month follow-up
|
Upper brachial artery flow-mediated dilation will be assessed using a standard protocol
|
Change from baseline to six-month follow-up
|
The Walking Impairment Questionnaire
Time Frame: Change from baseline to six-month follow-up
|
The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
|
Change from baseline to six-month follow-up
|
The SF-36 Physical Functioning Score
Time Frame: Change from baseline to six-month follow-up
|
This well validated quality of life measure will be used to assess changes in patient perceived quality of life.
|
Change from baseline to six-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary McDermott, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
June 30, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
February 13, 2017
First Submitted That Met QC Criteria
February 13, 2017
First Posted (Actual)
February 15, 2017
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00203784
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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