ClinicalTrials.gg
Active, not recruitingNCT05284266Updated Sep 22, 2025

The National Lipedema Study

An interventional study of Liposuction early and Liposuction late in Lipedema, sponsored by Haraldsplass Deaconess Hospital. Active, not recruiting at 1 site in Norway. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Haraldsplass Deaconess Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Lipedema

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Keywords

  • Liposuction
  • Conservative treatment
  • Intermittent pneumatic compression
  • Lipoedema
  • Compression therapy
  • Self management
  • Dietary management
03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's planned enrollment of 220 is above the median of 35 across 42 interventional studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Haraldsplass Deaconess Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • female
  • age 20-65 years
  • significant pain from lipedema
  • lipedema stage 1-2 or localized stage 3

Exclusion criteria

Exclusion Criteria:

  • Non-fluency in the Norwegian language
  • pregnancy
  • current
  • previous surgical treatment for lipedema
  • smoking
  • > 28
  • serious comorbidities such as cardiac-, pulmonary-, renal disease
  • unwillingness to wear compression garments
Terms in these criteria, in plain language(2)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    Standard conservative treatment

    Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician

    Other: Standard conservative treatment

  • Experimental
    Standard treatment plus additional lymphedema treatment

    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)

    Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)

  • Experimental
    Surgical group: Liposuction

    Early liposuction, 6-9 months after inclusion in study.

    Procedure: Liposuction early

  • Active comparator
    Surgical group: Control

    Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.

    Procedure: Liposuction late

Interventions

  • ProcedureLiposuction early

    Liposuction 6-9 months after inclusion

  • ProcedureLiposuction late

    Liposuction 18-21 months after inclusion

  • OtherStandard conservative treatment

    Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program

  • OtherStandard conservative treatment with Intermittent Pneumatic Compression (IPC)

    Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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)

    Time frame: 12 months after the last liposuction surgery

Other outcomes

  1. Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema

    Effect of two different conservative treatments strategies on pain and everyday activities (RAND-36)

    Time frame: 6 months after inclusion

  2. Adverse effect of liposuction

    Assess possible adverse effects of liposuction

    Time frame: 12 months after last liposuction surgery

  3. Effect of liposuction on the need for conservative treatment

    Assess whether having undergone liposuction changes the need for conservative treatment.

    Time frame: 3 years after last liposuction surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Data will be available after publication of outcomes.

Supporting information: Study protocol, Analytic code

Time frame: Data will be available after publication of outcomes.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05284266
Lead sponsor
Haraldsplass Deaconess Hospital
Collaborators
St. Olavs Hospital, University Hospital of North Norway, Sykehuset Telemark, University of Bergen, Klinbeforsk, Helse Vest
Responsible party
Hildur Skuladottir (Medical Doctor, PhD, Haraldsplass Deaconess Hospital) — Principal investigator
First posted
Mar 17, 2022
Start date
Mar 11, 2022
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Hildur Skuladottir, PhD
principal investigator · Haraldsplass Deaconess Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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