Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 12:18 AM
Study NCT ID:
NCT06180850
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-14
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Building Lipedema Research Resources
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065134', 'term': 'Lipedema'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A standard blood draw will be acquired. Up to 60 mL will be acquired in a 1-time visit.\n\nUrine collection procedures.\n\nTissue punch biopsy taken from the following locations:\n\nThe peri-umbilical region, right upper inner-thigh, left upper inner-thigh'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We will measure plasma concentrations of CD8A.', 'timeFrame': '1 day'}, {'measure': 'We will measure plasma concentrations of high-sensitivity C-reactive protein.', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'We will measure the 6-minute walk test.', 'timeFrame': '1 day'}, {'measure': 'We will measure the four-meter gait speed test.', 'timeFrame': '1 day'}, {'measure': 'We will measure the hand grip strength test.', 'timeFrame': '1 day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipedema']}, 'descriptionModule': {'briefSummary': "Lipedema is a disease marked by subcutaneous adipose tissue accumulation in the lower extremities of females that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity, although it's estimated to affect a high 11% of women. Clinical diagnosis of lipedema requires specialized training not widely available at most major medical centers, and there remains a substantial need for objective tools to distinguish lipedema from obesity. There is a critical need to define specific molecular markers of disease in circulation or at the tissue-level. The purpose of this study is to create, manage, and characterize an innovative lipedema biorepository. The goal of the biorepository will be to better understand disease mechanisms of lipedema and to define specific molecular markers of disease in circulation or at the tissue-level. The long-term purpose of our studies are to help with prevention and early management of lipedema."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with or without lipedema', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with or without lipedema\n* Age range = 18-80 years\n* Participants with lipedema have a formal diagnosis by a physician using criteria in Appendix A of protocol\n* Female\n\nExclusion Criteria: Volunteers in the lipedema or control group will be excluded with the following:\n\n* Pregnant or breast-feeding\n* Taking any anticoagulation or antiplatelet therapy other than aspirin (up to 100 mg daily)\n* Active infection anywhere in the body, or open wound on the lower-extremities or at locations for ultrasound, bioimpedance, and tissue dielectric measurements\n* Battery-operated device implanted that cannot be removed for ultrasound, DXA scan, bioimpedance, and tissue dielectric measurements\n* Primary lymphedema\n* Uncontrolled diabetes, renal disease, thyroid disease, or hypertension\n* Hormone dysregulation or another significant clinical condition affecting hormone status as confirmed by clinical co-investigators\n* Bone metastases\n* Contrast imaging scan in the previous 7 days\n* Nuclear medicine scan in previous 3 days\n* Lumbar spine fusion\n* Weigh more than 500 lb (226.8 kg)\n\nAlso excluded are subjects incapable of giving informed written consent:\n\n* Subjects who have an inability to communicate with the researcher for any reason\n* Subjects who are non-English speaking who cannot communicate through a translator, or if a translator is not available\n* Subjects who cannot adhere to the experimental protocols for any reason\n* Subjects who have limited mental ability to give informed consent due to mental disability, confusion, or psychiatric disorders\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06180850', 'acronym': 'BRR', 'briefTitle': 'Building Lipedema Research Resources', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Building Lipedema Research Resources', 'orgStudyIdInfo': {'id': '212427'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Participants with lipedema'}, {'label': 'Controls', 'description': 'Participants without lipedema'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Aaron W. Aday, MD, MSc', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}