NCT03271034: Lipedema

Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

Completed NA Last updated 28 March 2025

What this trial tests

NA trial testing Weight loss in Lipedema in 19 participants. Completed in 24 March 2025.

Timeline

1 August 2017

Primary endpoint
28 March 2023

24 March 2025

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 August 2017
Primary completion	28 March 2023
Estimated completion	24 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Weight loss — full drug profile →

Conditions studied

• Lipedema — all drugs for Lipedema →
• Metabolism — all drugs for Metabolism →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 68, female only, with Lipedema or Metabolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain and accumulation of fluid. Little is known about the functional changes that lead to fat accumulation and pain in women with lipedema. The goals of this project are to conduct a comprehensive characterization of abdominal and femoral fat tissues in lean and obese women with lipedema and to evaluate the potential effect of diet-induced weight loss as a therapy.

Once enrolled in the study, the following tests will be conducted on lean women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin) and adipose tissue biology. The following tests will be conducted on obese women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin), adipose tissue biology, and immune system function/inflammation. As control groups, we will compare body composition and insulin sensitivity to: i) women with obesity without lipedema who are matched on age, body mass index, total body fat mass, and percent body weight as fat; and ii) women who were lean and healthy to serve as a normal comparator for the 2 groups with obesity. Participants in the 2 control groups will enroll in a different study at Washington University (IRB# 201512086) where the same procedures will be performed to assess body composition and insulin sensitivity.

A second aim of the study is to determine the effect of diet-induced weight loss on body composition, insulin sensitivity, and adipose tissue biology in women with lipedema. The results from this second aim of the study will provide important insights on the efficacy of diet therapy in managing lipedema.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adipose Tissue Biology and Effect of Weight Loss in Women With Lipedema.
   Cifarelli V, Smith GI, Gonzalez-Nieves S, Samovski D, et al · · 2025 · cited 11× · PMID 39652636 · DOI 10.2337/db24-0890
2. Moderate weight loss decreases lipedema-affected body fat mass in a woman who is lean with lipedema.
   De Girolamo G, Smith GI, Stein RI, Wright TF, et al · · 2026 · PMID 41767202 · DOI 10.1210/jcemcr/luag018