LipedemaNCT05284266
The National Lipedema Study
A study testing Liposuction early, Liposuction late and Standard conservative treatment in people with Lipedema, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
Trial summary
Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- What is being tested?
- Liposuction early, Liposuction late and Standard conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- 11 Mar 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- age 20-65 years
- significant pain from lipedema
- lipedema stage 1-2 or localized stage 3
Who cannot join
- Non-fluency in the Norwegian language
- pregnancy
- current malignancy
- previous surgical treatment for lipedema
- smoking
- BMI > 28
- serious comorbidities such as cardiac-, pulmonary-, renal disease
- unwillingness to wear compression garments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Treatment of Lipedema in Norway - a National Multicenter Study
Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction.
Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking.
The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.
- Conditions
- Lipedema
- Being tested
- Liposuction early, Liposuction late, Standard conservative treatment, Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
- Keywords
- Liposuction, Conservative treatment, Intermittent pneumatic compression, Lipoedema, Compression therapy, Self management, Dietary management
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposuction earlyProcedure or surgery
Liposuction 6-9 months after inclusion
Liposuction lateProcedure or surgery
Liposuction 18-21 months after inclusion
Standard conservative treatmentOther
Standard Conservative treatment consisiting of:
Physical therapy, including compression garment and exercise program, Self-care program
Standard conservative treatment with Intermittent Pneumatic Compression (IPC)Other
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
| Study group | Role | What they receive |
|---|---|---|
| Standard conservative treatment | Active comparator | Standard conservative treatment consisting of:
* Physical therapy, including compression garment and exercise program
* Self-care program
* Individual counseling from a clinical dietician Receives: Other: Standard conservative treatment |
| Standard treatment plus additional lymphedema treatment | Experimental | Standard conservative treatment consisting of:
* Physical therapy, including compression garment and exercise program
* Self-care program
* Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC) Receives: Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC) |
| Surgical group: Liposuction | Experimental | Early liposuction, 6-9 months after inclusion in study. Receives: Procedure: Liposuction early |
| Surgical group: Control | Active comparator | Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group. Receives: Procedure: Liposuction late |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of liposuction on lipedema pain
Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS). VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (worst possible pain).
Measured: 12 months after the last liposuction surgery
Secondary outcomes (1)
Effect of liposuction on quality of life and everyday activities for patients with lipedema
Assess the effect of liposuction on quality of life and everyday activities (RAND-36)
Measured: 12 months after the last liposuction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start11 Mar 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment are evaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, Sykehuset Telemark, University of Bergen, Klinbeforsk, Helse Vest
- Responsible party
- Principal investigator, Hildur Skuladottir, Haraldsplass Deaconess Hospital
- Investigators
- Hildur Skuladottir, PhD, Principal investigator, Haraldsplass Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284266
- Sponsor's protocol ID
- 239087
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after publication of outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Lipedema in Norway - a National Multicenter Study
- ClinicalTrials.gov ID
- NCT05284266
- Acronym / sponsor ID
- 239087
- Conditions
- Lipedema
- Keywords
- Liposuction, Conservative treatment, Intermittent pneumatic compression, Lipoedema, Compression therapy, Self management, Dietary management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, Sykehuset Telemark, University of Bergen, Klinbeforsk, Helse Vest
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Mar 2022 (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 chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction.
Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking.
The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment are evaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Standard conservative treatment | Active comparator | Other: Standard conservative treatmentStandard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician |
| Standard treatment plus additional lymphedema treatment | Experimental | Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC) |
| Surgical group: Liposuction | Experimental | Procedure: Liposuction earlyEarly liposuction, 6-9 months after inclusion in study. |
| Surgical group: Control | Active comparator | Procedure: Liposuction lateLate liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female
- age 20-65 years
- significant pain from lipedema
- lipedema stage 1-2 or localized stage 3
Key exclusion criteria (8 listed)
- Non-fluency in the Norwegian language
- pregnancy
- current malignancy
- previous surgical treatment for lipedema
- smoking
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 |
|---|---|---|
| Liposuction earlyLiposuction 6-9 months after inclusion | Procedure or surgery | Surgical group: Liposuction |
| Liposuction lateLiposuction 18-21 months after inclusion | Procedure or surgery | Surgical group: Control |
| Standard conservative treatmentStandard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program | Other | Standard conservative treatment |
| Standard conservative treatment with Intermittent Pneumatic Compression (IPC)Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC) | Other | Standard treatment plus additional lymphedema treatment |
Primary outcome
Effect of liposuction on lipedema pain
Time frame: 12 months after the last liposuction surgery
Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS). VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (worst possible pain).
1 secondary outcome
Effect of liposuction on quality of life and everyday activities for patients with lipedema
Time frame: 12 months after the last liposuction surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. Data will be available after publication of outcomes.
Related trials for Lipedema
Recruiting
"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"
Lower-Limb Lipedema, Lipedema
Not yet recruiting
Telerehabilitation-Supported Exercise in Women With Lipedema
Lipedema
RecruitingObservational study
Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
Lipedema, Obesity
Recruiting
Comparison of Different Exercise Protocols for Diagnosed With Lipedema
Aerobic Exercise, Lipedema
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation-Enriched Rehabilitation in Individuals With Lipedema
Lipedema
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.
Hildur Skuladottir, PhD principal investigator
Haraldsplass Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction early, Liposuction late and Standard conservative treatment in people with Lipedema, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of liposuction on lipedema pain (time frame: 12 months after the last liposuction surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.