Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Patient reported quality of life outcome using LLIS
研究概览
简要总结
Lymphedema affects millions and currently lacks effective drug treatments, relying mainly on compression therapy. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown potential in managing obesity and diabetes, which can worsen lymphedema. Although anecdotal evidence suggests benefits of GLP-1 RAs for lymphedema patients, rigorous prospective studies are lacking. This study aims to evaluate the effectiveness of GLP-1 RAs in improving quality of life and clinical outcomes in lymphedema patients, thereby addressing a critical gap in literature and potentially offering a new treatment option.
详细描述
Research Protocol: GLP-1Ras - Investigator-Initiated Study
Principal Investigator: Joseph Dayan, MD, MBA
Title: Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
Background and Rationale
Introduction: Lymphedema is an incurable and relentless progressive disease marked by swelling of the upper or lower limb requiring life-long compression. Patients have a high risk of cellulitis and deteriorating quality of life. Lymphedema is a major public health problem with an estimated incidence in the United States of 5 million. There is no cure and no drug to treat this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older with unilateral upper or lower extremity lymphedema Limb volume > 5% BMI => 23 Oncology clearance if there is a cancer history
排除标准
- •Moderate to severe venous insufficiency Actively using GLP-1 RAs Known intolerance or adverse effect to GLP-1 RAs Medical history or morbidity where GLP-1 RAs are contraindicated as per patient's primary care provider such as MEN syndrome or history of thyroid cancer.
研究组 & 干预措施
Study arm
Participants will received GLP-1 RAs for 6 months to study the effects on lymphedema.
干预措施: GLP-1 Receptor Agonists (Drug)
结局指标
主要结局
Patient reported quality of life outcome using LLIS
时间窗: 6 months
Lymphedema Life Impact Scale
次要结局
- Physiological improvement(6 months)
研究者
Joseph Dayan
Principal Investigator
Advanced Reconstructive Surgery Alliance