LipedemaLipedemaNCT03271034
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
A study testing Weight loss in people with Lipedema and Metabolism, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 68 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema, Metabolism
- What is being tested?
- Weight loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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:
- Medical history \& physical exam
- Urine drug/pregnancy Test
- Blood pressure, pulse, height, weight
- Electrocardiogram (ECG)
- Blood tests for routine lab analyses
- Oral glucose tolerance test (OGTT)
- Screening Questionnaires
- Dual energy X-ray absorptiometry (DXA) scan to assess whole-body and leg fat mass
- Magnetic Resonance Imaging (MRI) to determine the amount of fat in the liver, abdomen (belly), and thigh.
- Metabolism study (hyperinsulinemic-euglycemic clamp procedure) to assess how well insulin works to control blood glucose (sugar) concentrations.
- Abdominal (belly) and thigh fat biopsies (women with obesity only)
- Immune function (performed in people with obesity and lipedema only).
- Conditions
- Lipedema, Metabolism
- Being tested
- Weight loss
- Keywords
- Lipedema, Metabolism, Body Composition, Fat Distribution, Immunology
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossDietary supplement
Participants will lose weight by utilizing a low caloric diet and meeting with a study dietitian and/or behaviorist weekly for ~4 months.
| Study group | Role | What they receive |
|---|---|---|
| Lean women with Lipedema | Experimental | Body composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss. Receives: Dietary Supplement: Weight loss |
| Women with Obesity and Lipedema | Experimental | 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. Receives: Dietary Supplement: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thigh subcutaneous adipose tissue volume
Thigh subcutaneous adipose tissue volume assessed by magnetic resonance imaging.
Measured: 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.
Measured: Baseline testing
Secondary outcomes (6)
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.
Measured: Baseline testing
Change in whole-body insulin sensitivity
Whole-body insulin sensitivity determined by using the hyperinsulinemic-euglycemic clamp procedure.
Measured: 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.
Measured: Baseline testing
Change in leg fat mass
Leg fat mass will be assessed by dual-energy x-ray absorptiometry (DXA).
Measured: 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.
Measured: 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.
Measured: Before and after 5-10% weight loss (3-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Aug 2017
- Primary completion28 Mar 2023
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Lipedema Foundation
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271034
- Sponsor's protocol ID
- 201702107
- Acronym
- Lipedema
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2017
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Adipose tissue RNA sequencing will be uploaded to Gene Expression Omnibus (GEO).
Publications
Cifarelli V, Smith GI, Gonzalez-Nieves S, Samovski D, Palacios HH, Yoshino J, Stein RI, Fuchs A, Wright TF, Klein S. Adipose Tissue Biology and Effect of Weight Loss in Women With Lipedema. Diabetes. 2025 Mar 1;74(3):308-319. doi: 10.2337/db24-0890.
PubMed 39652636
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
- ClinicalTrials.gov ID
- NCT03271034
- Acronym / sponsor ID
- Lipedema / 201702107
- Conditions
- Lipedema, Metabolism
- Keywords
- Lipedema, Metabolism, Body Composition, Fat Distribution, Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Lipedema Foundation
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Medical history \& physical exam
- Urine drug/pregnancy Test
- Blood pressure, pulse, height, weight
- Electrocardiogram (ECG)
- Blood tests for routine lab analyses
- Oral glucose tolerance test (OGTT)
- Screening Questionnaires
- Dual energy X-ray absorptiometry (DXA) scan to assess whole-body and leg fat mass
- Magnetic Resonance Imaging (MRI) to determine the amount of fat in the liver, abdomen (belly), and thigh.
- Metabolism study (hyperinsulinemic-euglycemic clamp procedure) to assess how well insulin works to control blood glucose (sugar) concentrations.
- Abdominal (belly) and thigh fat biopsies (women with obesity only)
- Immune function (performed in people with obesity and lipedema only).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean women with Lipedema | Experimental | Dietary Supplement: Weight lossBody composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss. |
| Women with Obesity and Lipedema | Experimental | Dietary Supplement: Weight lossBody composition, adipose tissue biology, insulin sensitivity and immune function/inflammation assessed before and after low-calorie diet therapy to achieve 5-10% weight loss. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossParticipants will lose weight by utilizing a low caloric diet and meeting with a study dietitian and/or behaviorist weekly for ~4 months. | Dietary supplement | Lean women with Lipedema, Women with Obesity and Lipedema |
Primary outcome
Change in thigh subcutaneous adipose tissue volume
Time frame: Before and after 5-10% weight loss (3-4 months)
Thigh subcutaneous adipose tissue volume assessed by magnetic resonance imaging.
Whole-body insulin sensitivity
Time frame: Baseline testing
Whole-body insulin sensitivity determined by using the hyperinsulinemic-euglycemic clamp procedure between women with obesity and women with obesity and lipedema.
6 secondary outcomes
Thigh subcutaneous adipose tissue volume
Time frame: Baseline testing
Change in whole-body insulin sensitivity
Time frame: Before and after 5-10% weight loss (3-4 months)
Leg fat mass
Time frame: Baseline testing
Change in leg fat mass
Time frame: Before and after 5-10% weight loss (3-4 months)
Adipose tissue immune cells
Time frame: Baseline testing
Change in adipose tissue immune cells
Time frame: Before and after 5-10% weight loss (3-4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Results publication: PubMed 39652636Cifarelli V, Smith GI, Gonzalez-Nieves S, Samovski D, Palacios HH, Yoshino J, Stein RI, Fuchs A, Wright TF, Klein S. Adipose Tissue Biology and Effect of Weight Loss in Women With Lipedema. Diabetes. 2025 Mar 1;74(3):308-319. doi: 10.2337/db24-0890.
- Individual participant dataSharing planned: Yes. Adipose tissue RNA sequencing will be uploaded to Gene Expression Omnibus (GEO).
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Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Lipedema and Metabolism, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thigh subcutaneous adipose tissue volume (time frame: Before and after 5-10% weight loss (3-4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.