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Improve PAD PERformance With METformin (PERMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054519
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Metformin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improve PAD Performance With Metformin: The PERMET Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin
Metformin daily
Drug: Metformin
Participants will be prescribed up to 2,000 mgs daily of metformin

Placebo Comparator: Placebo
Placebo daily for six months.
Drug: Placebo
Placebo pills will appear identical to the metformin to maintain blinding of participants and investigators.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Maximal treadmill walking time [ Time Frame: Change from baseline to six-month follow-up ]
    A Gardner treadmill exercise protocol will be used

  2. 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

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054519


Contacts
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Contact: Mary McDermott, MD 312-503-6419 mdm608@northwestern.edu
Contact: Kathryn Domanchuk, BS 312-503-6438 k-domanchuk@northwestern.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Emilie Schmidt    352-376-1611    Emilie.schmidt@surgery.ufl.edu   
Principal Investigator: Scott Berceli, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary McDermott, MD    312-503-6419    mdm608@northwestern.edu   
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Tamar Polonsky, MD    312-608-0250    tpolonsky@bsd.uchicago.edu   
Principal Investigator: Tamar Polonsky, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Lydia Bazzano, MD    504-842-4747    lbazzano@tulane.edu   
Principal Investigator: Lydia Bazzano, MD         
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Lydia Bazzano, MD    504-842-4747    lbazzano@tulane.edu   
Principal Investigator: Lydia Bazzano, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Mary McDermott, MD Northwestern University
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Responsible Party: Mary McDermott, Professor of Medicine at Northwestern University Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT03054519    
Other Study ID Numbers: STU00203784
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs