40 Participants Needed

Metformin for Achilles Tendinopathy

JH
Overseen ByJames H Wang, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether metformin, a common diabetes medication, can alleviate chronic Achilles tendon pain and enhance tendon healing. Participants will receive either metformin capsules or placebo pills for 16 weeks, alongside a home exercise program. The trial aims to compare the effectiveness of metformin to a placebo. Individuals with ongoing Achilles tendon pain (also known as Achilles tendinopathy) who have not had recent interventions or surgeries may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants an opportunity to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as diabetic medications like sitagliptin and carbonic anhydrase inhibitors like topiramate. If you are currently taking metformin or have taken it in the last 6 months, you cannot participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that metformin is generally safe for use. One study found that metformin can help protect tendons from damage by activating a specific process in the body, suggesting it might be a safe option for treating tendon problems. As a common drug for managing diabetes, much is known about its safety. Most people taking metformin experience few side effects, though some might have mild stomach issues. However, this trial is in its early stages, so while metformin appears promising, researchers are still studying its effects on Achilles tendon pain.12345

Why do researchers think this study treatment might be promising for Achilles tendinopathy?

Unlike the standard treatments for Achilles tendinopathy, which often include physical therapy, NSAIDs, or corticosteroid injections, metformin offers a novel approach by leveraging its anti-inflammatory and metabolic effects. Metformin, commonly known for managing diabetes, may help reduce inflammation and improve tendon healing, which is a new mechanism for this condition. Researchers are excited because this approach could offer a non-invasive and potentially more effective treatment option, addressing the root causes of tendinopathy rather than just alleviating symptoms.

What evidence suggests that metformin might be an effective treatment for Achilles tendinopathy?

Research suggests that metformin might help with Achilles tendon pain. In animal studies, metformin injections prevented tendon problems and reduced swelling in the Achilles tendon by blocking a protein that causes inflammation. While these results are promising, they mostly come from animal studies. This trial will compare the effects of metformin with a placebo in people with long-term Achilles tendon pain to study its effectiveness in humans.12467

Who Is on the Research Team?

JH

James H Wang, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for non-diabetic individuals with chronic Achilles tendon pain who can consent to participate, have a specific level of disability due to the pain, and show signs of tendon damage on an ultrasound. They must not have had recent treatments or surgery on the tendon, be pregnant or breastfeeding, suffer from systemic inflammatory diseases or severe liver problems, take certain medications like metformin recently, or have a BMI over 30.

Inclusion Criteria

Willing and able to provide informed consent for participation
Ability to read, speak, and understand English
I have been diagnosed with Achilles tendinopathy.
See 2 more

Exclusion Criteria

Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
You have a history of lactic acidosis or high levels of lactate in your body.
I have severe liver problems.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive metformin or placebo capsules combined with a home exercise program for 16 weeks

16 weeks
3 visits (in-person) at baseline, week 4, and week 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin
  • Placebo
Trial Overview The study is testing if taking metformin pills helps reduce tendon pain and aids in healing compared to placebo (dummy pills). Both groups will also follow a home exercise program. There are two groups: one receiving metformin capsules for 16 weeks and another receiving placebo tablets for the same duration.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group, Metformin CapsulesExperimental Treatment1 Intervention
Group II: Placebo Group, Placebo CapsulesPlacebo Group1 Intervention

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in China as Glucophage for:
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Approved in Switzerland as Glucophage for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

James Wang

Lead Sponsor

Trials
1
Recruited
40+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Published Research Related to This Trial

In a study of 1986 adults with type 2 diabetes, gliclazide modified release (MR) was found to be more effective than sitagliptin in achieving target HbA1c levels, with higher rates of reaching HbA1c <7.0% and HbA1c ≀6.5%.
Both treatments showed similar durability and persistence, and hypoglycaemic events were rare, indicating that gliclazide MR is a safe and effective second-line option for patients already on metformin.
Comparative effectiveness of gliclazide modified release versus sitagliptin as second-line treatment after metformin monotherapy in patients with uncontrolled type 2 diabetes.Zaccardi, F., Jacquot, E., Cortese, V., et al.[2022]
A review of 10 studies involving over 1.4 million patients found that dipeptidyl peptidase-4 inhibitors (Dpp-4i) do not significantly increase the risk of developing rheumatoid arthritis, with a relative risk of 0.96.
The analysis suggests that Dpp-4 inhibitors are safe in terms of rheumatoid arthritis risk, but long-term monitoring of patients is still recommended.
Systematic review and meta-analysis: dipeptidyl peptidase-4 inhibitors and rheumatoid arthritis risk.Wang, M., Li, M., Xie, Y.[2021]
In a study of 862 participants with knee osteoarthritis, diabetes, and/or obesity, regular use of metformin was associated with a significantly reduced risk of total knee arthroplasty (TKA), with a prevalence ratio of 0.26, indicating a strong protective effect.
Metformin use also correlated with a reduction in knee pain severity, showing a decrease of 0.48 on the numeric rating scale, suggesting it may help manage symptoms in patients with metabolic-associated osteoarthritis.
Association between Metformin Use and Risk of Total Knee Arthroplasty and Degree of Knee Pain in Knee Osteoarthritis Patients with Diabetes and/or Obesity: A Retrospective Study.Chen, S., Ruan, G., Zeng, M., et al.[2023]

Citations

Effect of Metformin on Development of Tendinopathy Due ...Inhibition of HMGB1 by injections of Met prevented tendinopathy development due to mechanical overloading in the Achilles tendon in mice.
Managing Chronic Tendon Pain by MetforminThe purpose of the current exploratory clinical trial is to determine the effect of oral ingestion of metformin (OIM) in non-diabetic patients with chronic ...
Metformin lotion as a novel approach to prevent ...This study evaluated a novel topical metformin lotion (ML) for its ability to prevent Achilles tendinopathy induced by intensive treadmill ...
Metformin Improves Tendon Degeneration by Blocking ...We report that Met injection was able to reduce tendon inflammation and senescence, improve Achilles tendon degenerative changes by blocking HMGB1 translocation ...
Metformin for Achilles TendinopathyTrial Overview The study is testing if taking metformin pills helps reduce tendon pain and aids in healing compared to placebo (dummy pills). Both groups will ...
Metformin Administration Protects Against Deltoid Tendon ...These data demonstrate that metformin administration protects against tendon damage by activating Notch signaling. Strict control of T2DM has been proposed ...
Metformin Administration Protects Against Deltoid Tendon ...In this study, we found that T2DM patients had a significantly higher prevalence of tendon surgery compared to non-T2DM patients, which were ...
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