Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2016-06-30
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lipedema
Women with all stages of lipedema
No interventions assigned to this group
Dercum's disease
Men and women with nodular, mixed and diffuse Dercum's disease
No interventions assigned to this group
Control
Sex, age and BMI matched controls.
No interventions assigned to this group
Familial Multiple Lipomatosis
Women and men with multiple lipomas and/or angiolipomas
No interventions assigned to this group
Madelung's disease
Men and women with different types of Madelung's disease.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 19-70 years of age.
3. Diagnosis of lipedema, Dercum's disease or familial multiple lipomatosis or other similar fat disorder.
4. Individuals without a fat disorder (will be matched by age, sex, race and body mass index to individuals in "2").
5. Weight stable for past three months within a 10 pound range per personal report of the subject.
6. Overweight or obese (BMI \> 26 kg/m2) in order to be able to get enough SAT for the biopsy.
7. Individuals with BMI \< 26 kg/m2 may participate in all aspects of the study protocol except the SAT biopsy.
8. Thyroid levels in the normal range as confirmed by a TSH level. May have treated hypothyroidism that is stable over 6 months.
Exclusion Criteria
2. Subjects will be excluded from having a SAT biopsy with any history of scleroderma, keloid formation or other skin condition that would result in substantial scarring after biopsy, a history of recurrent cellulitis, any history of bleeding diathesis that would place the subject at great risk for persistent bleeding after a biopsy/liposuction, any history of major complication after a previous biopsy including requirement of a blood transfusion, hospitalization, failure to heal, or major infection, requiring intravenous antibiotics, or anyone whose skin and tissue would put them at risk for an infection after the biopsy per the assessment of study staff and the principal investigator. These individuals may participate in the remainder of the protocol, just not the SAT biopsy.
3. Use of any immunosuppressant or corticosteroid medication.
4. Use of any anti-inflammatory medication such as NSAIDs, aspirin, histamine (H) 1 blocker, H2 blocker, tetracycline or corticosteroids within five days of the study procedure visit.
5. Use of medications that might cause weight gain (e.g., second generation anti-psychotics).
6. Blood donation less than 56 days prior to screening visit.
7. Tobacco or marijuana use which may alter inflammation in the body.
8. Any antibiotics within the last month.
9. Barium enema in the last week which would affect gut bacteria and the MRI.
10. Pregnancy due to the risks associated with the fat biopsy in the area of the fetus and because pregnancy will alter hormone levels.
19 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lipedema Foundation
OTHER
University of Arizona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
KHerbst
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen L Herbst, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona College of Medicine (South Campus)
Tucson, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Allen M, Schwartz M, Herbst KL. Interstitial Fluid in Lipedema and Control Skin. Womens Health Rep (New Rochelle). 2020 Oct 14;1(1):480-487. doi: 10.1089/whr.2020.0086. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1602399502A001
Identifier Type: -
Identifier Source: org_study_id