An interventional study of Weight loss in Lipedema and Metabolism, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
Among 16 studies in Lipedema with a site in United States — 2 open to participants now, 3 under way, none of them phase 3. Lipedema · United States.
Among the 16 studies in Lipedema with a site in United States, this one is the only one that started in 2017, is one of 6 with no phase, and was the 4th registered.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 19 is below the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →2 of the 16 studies in Lipedema with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 19 Lipedema studies recruiting now, 3 (16%) set no upper age limit and 16 (84%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 68 Years · female · healthy volunteers too.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
Median enrollment 19 across the 9 interventional studies, 144 across the 7 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
5 of 16 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 1 study filed under Lipedema — fewer than ten, so there is no comparison to draw.
1 of the studies in Lipedema with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05464927University of VirginiaVisualizing Vascular Mechanisms of Lipedema | 2027-01-01 |
Among the 16 studies in Lipedema with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Once informed consent has been obtained, participants will complete a screening visit that will include a medical history, physical examination, pregnancy test (for women of childbearing potential), blood tests, urine drug test, an oral glucose tolerance test, resting electrocardiogram (ECG), and questionnaires.
Baseline testing will be performed over 2 visits requiring 1 inpatient overnight stay and will require approximately 30 hours in total to complete testing. Testing will include magnetic resonance imaging scans to determine thigh fat mass; abdominal (belly) fat mass and liver fat content; DXA scan to assess whole-body and leg fat mass; blood samples; hyperinsulinemic-euglycemic clamp procedure to assess insulin sensitivity; immune system function/inflammation (performed exclusively in people with obesity and lipedema and BMI-matched controls); and adipose tissue (fat) biopsies.
Once Baseline Testing is completed, participants will start 5-10% dietitian and/or behaviorist guided weight-loss for about 4 to 6 months.
Participant will keep a food diary and have weekly visits (in person or remote) with a study dietitian and/or behaviorist.
After weight loss, the testing completed during baseline will be repeated.
Study procedures:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Body composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.
Dietary Supplement: Weight loss
Body composition, adipose tissue biology, insulin sensitivity and immune function/inflammation assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.
Dietary Supplement: Weight loss
Participants will lose weight by utilizing a low caloric diet and meeting with a study dietitian and/or behaviorist weekly for \~4 months.
Change in thigh subcutaneous adipose tissue volume
Thigh subcutaneous adipose tissue volume assessed by magnetic resonance imaging.
Time frame: Before and after 5-10% weight loss (3-4 months)
Whole-body insulin sensitivity
Whole-body insulin sensitivity determined by using the hyperinsulinemic-euglycemic clamp procedure between women with obesity and women with obesity and lipedema.
Time frame: Baseline testing
Thigh subcutaneous adipose tissue volume
Thigh subcutaneous adipose tissue volume assessed by magnetic resonance imaging in women with obesity and lipedema, women with obesity and lean women.
Time frame: Baseline testing
Change in whole-body insulin sensitivity
Whole-body insulin sensitivity determined by using the hyperinsulinemic-euglycemic clamp procedure.
Time frame: Before and after 5-10% weight loss (3-4 months)
Leg fat mass
Leg fat mass will be assessed by dual-energy x-ray absorptiometry (DXA) in women with obesity and lipedema, women with obesity and lean women.
Time frame: Baseline testing
Change in leg fat mass
Leg fat mass will be assessed by dual-energy x-ray absorptiometry (DXA).
Time frame: Before and after 5-10% weight loss (3-4 months)
Adipose tissue immune cells
Immune cell numbers in upper and lower body subcutaneous adipose tissue stromal vascular fraction content assessed by flow cytometry in women with obesity and lipedema only.
Time frame: Baseline testing
Change in adipose tissue immune cells
Immune cell numbers in upper and lower body subcutaneous adipose tissue stromal vascular fraction content assessed by flow cytometry.
Time frame: Before and after 5-10% weight loss (3-4 months)
Adipose tissue transcriptomics
Gene expression in abdominal and thigh subcutaneous adipose tissue will be analyzed and compared by using RNA sequencing in women with lipedema.
Time frame: Baseline testing
Change in abdominal subcutaneous adipose tissue transcriptomics
Gene expression in abdominal subcutaneous adipose tissue will be analyzed by using RNA sequencing.
Time frame: Before and after 5-10% weight loss (3-4 months)
Change in thigh subcutaneous adipose tissue transcriptomics
Gene expression in thigh subcutaneous adipose tissue will be analyzed by using RNA sequencing.
Time frame: Before and after 5-10% weight loss (3-4 months)
Plan to share: Yes — Adipose tissue RNA sequencing will be uploaded to Gene Expression Omnibus (GEO).
Time frame: Before publication of manuscript containing RNA sequencing results
Access criteria: RNA sequencing results will be publicly available.
Data sharing details ↗ · www.ncbi.nlm.nih.gov
Ran from Aug 2017 to primary completion in Mar 2023, 67 months.
Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 67 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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