Yükleniyor... / Loading...
This study investigates the effects of weight loss on body composition and metabolic function in women with lipedema. It was designed for lean or obese women with a diagnosis of lipedema. The study was conducted as a trial without an assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Diagnosis of Lipedema * Lean women with lipedema (BMI \>19.5 kg/m² and \<26.0 kg/m²) * Women with obesity and lipedema (BMI \>30.0 kg/m² and \<50.0 kg/m²) Exclusion Criteria: * Medical, surgical or biological menopause * Previous bariatric surgery * Diagnosis of Type 2 Diabetes * HbA1C \<5.7% * Structured exercise \>2 days/week for ≥35 minutes of intense exercise (e.g., jogging, activity that cause heavy breathing and sweating) or ≥150 minutes per week of structured exercise (e.g., brisk walking) * Unstable weight (\>4% change in weight during the last 2 months before entering the study) * Significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease) * Cancer or cancer that has been in remission for \<5 years * Polycystic Ovary Syndrome * Major psychiatric illness * Conditions that render participant unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders) * Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study * Smoke cigarettes \>10 cigarettes/week * Consume \>14 units of alcohol per week * Pregnant or lactating women * Persons who are not able to grant voluntary informed consent * Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.