110 Participants Needed

GLP-1 Receptor Agonists for Lymphedema

Recruiting at 1 trial location
GT
ST
Overseen BySaba Tasawar
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Advanced Reconstructive Surgery Alliance
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist those with lymphedema, a condition where fluid accumulates and causes swelling in the arms or legs. Researchers are testing GLP-1 receptor agonists, drugs effective in treating obesity and diabetes, to determine if they can also improve symptoms and quality of life for lymphedema patients. The trial targets adults with noticeable swelling in one arm or leg who are not currently using these specific drugs. For those who have tried other treatments but still face daily challenges due to lymphedema, this trial might be suitable. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently using GLP-1 receptor agonists, you cannot participate in the trial.

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

Studies have shown that GLP-1 receptor agonists (GLP-1 RAs) are generally well-tolerated by patients. Research indicates that people without diabetes who took GLP-1 RAs had an 84% lower chance of developing lymphedema compared to those who did not take them. This suggests the treatment might be safe and even beneficial for lymphedema patients. However, some reports mention skin-related side effects, such as rashes or blisters, so monitoring for these reactions is important. Overall, while promising evidence exists, more studies are needed to fully understand the safety for lymphedema patients.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lymphedema, which often focus on physical therapies like compression garments and manual lymphatic drainage, GLP-1 receptor agonists offer a novel approach by targeting metabolic pathways. Researchers are excited about these treatments because GLP-1 receptor agonists, typically used for diabetes and weight management, may reduce inflammation and improve lymphatic function, addressing the underlying causes of lymphedema rather than just the symptoms. This unique mechanism of action could provide a more effective and lasting solution for patients.

What evidence suggests that GLP-1 Receptor Agonists might be an effective treatment for lymphedema?

Research has shown that GLP-1 receptor agonists (GLP-1 RAs) might help with lymphedema, a condition causing swelling due to fluid buildup. One study found that people without diabetes who took GLP-1 RAs were 84% less likely to develop lymphedema compared to those who did not take them. Some reports also indicate a significant reduction in swelling and even the possibility of stopping compression therapy in certain cases. These drugs are already used to manage obesity and diabetes, which can worsen lymphedema. While more research is needed, these early findings are promising for using GLP-1 RAs to treat lymphedema. Participants in this trial will receive GLP-1 RAs for 6 months to study their effects on lymphedema.12367

Are You a Good Fit for This Trial?

This trial is for individuals with lymphedema, particularly after mastectomy. It's designed to see if a medication typically used for obesity and diabetes can help reduce swelling and improve quality of life in these patients.

Inclusion Criteria

One of my limbs is swollen by more than 5% compared to the other.
I have clearance from an oncologist for my cancer history.
BMI >= 23
See 1 more

Exclusion Criteria

I have moderate to severe problems with my vein circulation.
I am currently taking GLP-1 receptor agonists.
I cannot take GLP-1 RAs due to my medical history, like MEN syndrome or thyroid cancer.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 RA treatment administered by their primary provider

6 months
Baseline, 3 months, and 6 months post-treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Follow-up visits at 3 months and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • GLP-1 Receptor Agonists
Trial Overview The study tests GLP-1 receptor agonists, drugs usually prescribed for weight loss and diabetes management, to determine their effectiveness in treating limb swelling due to lymphedema.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Advanced Reconstructive Surgery Alliance

Lead Sponsor

Trials
2
Recruited
750+

Citations

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may ...The odds of developing lymphedema were 84% lower for patients without diabetes treated with GLP1-RAs compared to those who did not receive GLP-1 RAs (OR 0.16, ...
Efficacy of GLP-1 Receptor Agonists in Treating Upper and ...Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown potential in managing obesity and diabetes, which can worsen lymphedema.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) ...... results. In addition to weight loss, GLP-1RAs may affect lymphedema, given their beneficial effects on glucose control. In this study ...
GLP-1 receptor agonist as an effective treatment for breast ...We have observed by all objective measures a significant reduction in lymphedema and the elimination of compression in the case presented as a ...
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) ...The odds of developing lymphedema were 84% lower for patients without diabetes treated with GLP1-RAs compared to those who did not receive GLP-1 ...
Benefit-Risk Assessment of GLP-1 Receptor AgonistsHowever, GLP-1 RAs are also associated with emerging cutaneous adverse drug reactions, including bullous, exanthematous and vasculitic ...
Semaglutide Treatment in a Patient with Extreme Obesity ...After 6 weeks of liraglutide treatment and 26 weeks of semaglutide treatment, the patient had lost 79.5 kg (−25.2% of TBW). More data are needed ...
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