Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT03271034
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT03271034
Study Brief:
Protocol Section:
NCT03271034