[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593915":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":17,"centralContacts":38,"locations":48,"responsibleParty":87,"collaborators":17,"id":90,"slug":17,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":17,"eligibilityCriteria":94,"healthyVolunteers":91,"sex":95,"minAge":96,"maxAge":17,"enrollmentInfo":97,"targetDuration":17,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Advanced Reconstructive Surgery Alliance","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Patient reported quality of life outcome using LLIS","Lymphedema Life Impact Scale","6 months",[14],{"measure":15,"description":16,"timeFrame":12},"Physiological improvement","Limb volume Bioimpedance BMI Incidence of cellulitis Compression use",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","Research Protocol: GLP-1Ras - Investigator-Initiated Study\n\nPrincipal Investigator: Joseph Dayan, MD, MBA\n\nTitle: Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema\n\nBackground and Rationale\n\nIntroduction: 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.\n\nLiterature Review: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are now ubiquitous in the United States given their effectiveness in treating obesity and diabetes. Elevated BMI and insulin resistance have been widely reported to worsen lymphedema. Consequently, GLP-1 RAs may have a positive effect on lymphedema. Anecdotally we have observed patients with chronic lymphedema dramatically improve after taking GLP-1 receptor agonists but there is currently no prospective data available.\n\nRationale: 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.\n\nObjectives\n\nPrimary Objective: To evaluate the quality-of-life improvements following GLP-1 RA treatment, utilizing the Lymphedema Life Impact Scale (LLIS) as a measurement tool.\n\nSecondary Objectives: To evaluate the efficacy of GLP-1 RAs in reducing limb volume, bioimpedance, compression use, and incidence of cellulitis.\n\nHypotheses\n\nGLP-1 receptor agonists will improve quality of life and reduce limb volume in lymphedema patients.\n\nStudy Design\n\nType of Study: Prospective, Single arm study, off-label use of GLP-1 receptor agonists to treat upper or lower extremity lymphedema.\n\nDuration: 24 Months\n\nStudy Setting: Conduct at an outpatient lymphedema clinic\n\nPopulation: Adults with Upper and lower extremity Lymphedema, (ISL) stages II and II\n\nSample Size: 110 participants\n\nFollow-up Visits: Baseline, 3 months, and 6 months post-treatment visit\n\nParticipants\n\nEligibility Criteria\n\nInclusion Criteria:\n\nAdults 18 years or older with unilateral upper or lower extremity lymphedema Limb volume \\> 5% BMI =\\> 23 Oncology clearance if there is a cancer history\n\nExclusion Criteria:\n\nModerate 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\n\nMethods\n\nData Collection:\n\nLymphedema Life Impact Scale score (validated patient-reported outcome metric) Limb volume Bioimpedance BMI Compression use Incidence of cellulitis\n\nInterventions: GLP-1 RA treatment will be administered by the patient's primary provider for 6 months.\n\nOutcome Measures\n\nPrimary Outcome:\n\nPatient reported quality of life outcome (Lymphedema Life Impact Scale)\n\nSecondary Outcomes:\n\nLimb volume Bioimpedance BMI Incidence of cellulitis Compression use\n\nData Analysis Plan\n\nStatistical Methods:\n\nUtilize appropriate statistical tests, including a t-test with an effect size of 0.15 and a power of 0.95.\n\nTo adequately power this study, 74 participants are needed to complete a 6-month course of GLP-1 RA treatment and follow-up. Assuming a dropout rate of 30%, we plan to enroll 110 patients to meet this goal.\n\nSoftware:\n\nIBM SPSS for data analysis.\n\nHandling Missing Data:\n\nTo address missing data, all instances will be documented, and efforts will be made to recover missing information. Multiple imputation techniques will be used to estimate missing values for continuous variables, such as limb volume and LLIS scores. Sensitivity analyses will be conducted to evaluate the impact of missing data on study outcomes, ensuring robustness and transparency in the study's findings.\n\nEthical Considerations\n\nInformed Consent:\n\nParticipants will provide informed consent, understanding the study's scope and procedures.\n\nConfidentiality:\n\nParticipant data will be kept confidential, adhering to ethical standards.\n\nApproval:\n\nEthical approval will be obtained from a relevant ethics committee or institutional review board (IRB).\n\nStudy Timeline Estimated Start Date: April 9, 2025\n\nEstimated Completion Date: April 9, 2027\n\nRecruitment:\n\nRecruit patients from internal lymphedema population Clinicaltrials.gov Patient referrals from other providers and social media\n\nBudget and Funding\n\nBudget:\n\nNo anticipated study costs. The study participation is voluntary\n\nFunding Sources:\n\nThe project is currently not funded\n\nPotential Risks and Benefits\n\nRisks, benefits, and alternatives to GLP-1 RA treatment will be discussed with the patient in addition to the patient reviewing this consideration with their provider.\n\nThe most common adverse event from GLP-1 treatment is gastrointestinal intolerance such as nausea or vomiting (5% incidence).\n\nAdverse events:\n\nThe site will begin to report AE\u002FSAE after the patient signs the informed consent.\n\nAll serious adverse events (SAEs) will be documented and reported to the Institutional Review Board (IRB) within 24 hours of the patient site becoming aware.\n\nParticipant Discontinuation\u002F Withdrawal from the study:\n\nParticipants have the right to withdraw from the study at any time upon their request.\n\nDissemination Plan:\n\nThe results of the study will be submitted as a research manuscript for publication in a peer-reviewed journal either the New England Journal of Medicine or the Journal of the American Medical Association.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Study arm","EXPERIMENTAL","Participants will received GLP-1 RAs for 6 months to study the effects on lymphedema.",[31],"Drug: GLP-1 Receptor Agonists",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"DRUG","GLP-1 Receptor Agonists","GLP-1 RAs in lymphedema",[27],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},"Giana Truax","CONTACT","866-266-2577","gtruax@sycamoremm.com",{"name":45,"role":41,"phone":46,"phoneExt":17,"email":47},"Saba Tasawar","732-741-0970","stasawar@sycamoremm.com",[49,69],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"River Center","RECRUITING","Red Bank","New Jersey","07701","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.06431,40.34705,{"lat":61,"lon":60},[64,67],{"name":40,"role":41,"phone":65,"phoneExt":66,"email":43},"8662662577","1860",{"name":45,"role":41,"phone":68,"phoneExt":17,"email":47},"7327410970",{"facility":70,"status":51,"city":71,"state":53,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"260 Old Hook Rd Suite 304","Westwood","07675",{"type":58,"coordinates":74},[75,76],-74.03264,40.99121,{"lat":76,"lon":75},[79,84],{"name":80,"role":41,"phone":81,"phoneExt":82,"email":83},"Ivette Chacon","848-272-2772","1641","ichacon@sycamoremm.com",{"name":85,"role":86,"phone":17,"phoneExt":17,"email":17},"Joseph Dayan, MD","PRINCIPAL_INVESTIGATOR",{"type":86,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Joseph Dayan","Principal Investigator","100593915",false,"NCT07012642","Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema","Inclusion Criteria:\n\nAdults 18 years or older with unilateral upper or lower extremity lymphedema Limb volume \\> 5% BMI =\\> 23 Oncology clearance if there is a cancer history\n\nExclusion Criteria:\n\nModerate 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.","ALL","18 Years",{"count":98,"type":99},110,"ESTIMATED","INTERVENTIONAL",[102],"EARLY_PHASE1","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.",[105],"Lymphedema",[107],"Efficacy of GLP-1 in lymphedema","2025-06-01",{"date":110,"type":111},"2025-06-10","ACTUAL",{"date":113,"type":111},"2025-04-09",{"date":115,"type":99},"2027-04-09",{"name":5,"class":6},2]