Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-05-24
2026-08-31
Brief Summary
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Detailed Description
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Group 1: Home Exercise Program + Placebo as a control group
Group 2: Home Exercise Program + Oral Ingestion of Metformin
Patients in group 1 will receive placebo capsules,1 capsule (500 mg) daily for week one, 2 capsules (1,000 mg) daily for week two, 3 capsules daily for week 3 (1,500 mg), and 4 capsules daily (2,000 mg) for weeks 4-16. Patients in group 2 will receive metformin capsules,1 capsule (500 mg) daily for week one, 2 capsules (1,000 mg) daily for week two, 3 capsules daily for week 3 (1,500 mg), and 4 capsules daily (2,000 mg) for weeks 4-16. All patients will participate in a home exercise program through MedBridge, a HIPAA-compliant participant portal currently used by physical therapists at University of Pittsburgh Medical Center. There are 3 visits for this study. Visits include a Screening/Baseline visit, week 4 and week 16 visit. During each visit, participants will answer questions, complete functional testing, and undergo an ultrasound of the Achilles Tendon.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Group, Placebo Capsules
Placebo Group (n=20) Week 1: One placebo capsule (500 mg) daily Week 2: Two placebo capsules (1,000 mg) daily Week 3: Three placebo capsules (1,500 mg) daily Week 4-16: Four placebo capsules (2,000 mg) daily
Placebo
500 mg capsules of placebo pills
Treatment Group, Metformin Capsules
Treatment Group (n=20) Week 1: One metformin ER capsule (500 mg) daily Week 2: Two metformin (ER) capsules (1,000 mg) daily Week 3: Three metformin (ER) capsules (1,500 mg) daily Week 4-16: Four metformin (ER) capsules (2,000 mg) daily
Metformin
500 mg capsules of Metformin Extended Release
Interventions
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Metformin
500 mg capsules of Metformin Extended Release
Placebo
500 mg capsules of placebo pills
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Achilles tendinopathy
* Pain disability index score of between 20 - 70 points (0-100 scale VISA-A)
* Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture.
* Ability to read, speak, and understand English
Exclusion Criteria
* Previous Achilles tendon surgery.
* Known platelet abnormality or hematological disorder.
* Presence of other conditions that might affect the functional scale of the indexed limb.
* Unwillingness to be randomized.
* Body Mass Index (BMI) greater than 30.
* Occult tear in the indexed tendon.
* Systemic inflammatory disease.
* Use of fluoroquinolone in the past 6 months.
* Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
* Chronic kidney disease (eGFR \<60)
* Diagnosis of diabetes mellitus or elevated HbA1c at screening (\> 6.5)
* Unable to take an oral medication in a non crushable pill form
* Taking metformin presently or within the last 6 months
* History of allergy to metformin
* History of lactic acidosis or elevated lactate at screening (\> 2.2)
* Severe Hepatic dysfunction
* Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
* Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
* Currently taking cimetidine
18 Years
50 Years
ALL
No
Sponsors
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United States Department of Defense
FED
James Wang
OTHER
Responsible Party
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James Wang
Professor
Principal Investigators
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James H Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica Eldridge
Role: primary
Other Identifiers
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HT9425-23-1-0712
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY23040151
Identifier Type: -
Identifier Source: org_study_id