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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05394467
Eligibility Criteria:
Inclusion Criteria:
* BMI ≤50 kg/m2
* Waist/hip ratio \<0.86 (standing position)
* Clinical diagnosis of lipedema (mostly Stage 3 but Stage 2 will not be excluded)
* Willing to drink deuterated water (2H2O)
Exclusion Criteria:
* Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
* Chronic use of systemic glucocorticoids, atypical anti-psychotic medications, or medications that cause clinically significant changes in weight
* Pregnancy or breastfeeding in the next 3 months
* Partial and/or full hysterectomy (due to estrogen effects on adipogenesis)
* PCOS
* Self-reported positive test for HIV, hepatitis B and hepatitis C
* Smoking or use of tobacco products in the last 6 months
* Any medical, psychiatric or behavioral factors that may interfere with study participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05394467
Study Brief:
Protocol Section:
NCT05394467