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Active, Not Recruiting

NCT Number: NCT05284266

The National Lipedema 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haraldsplass Deaconess Hospital

Bergen, 5009, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Liposuction early

Procedure

Liposuction 6-9 months after inclusion

Liposuction late

Procedure

Liposuction 18-21 months after inclusion

Standard conservative treatment

Other

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)

Primary outcomes

  1. 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).

Secondary outcomes

  1. Effect of liposuction on quality of life and everyday activities for patients with lipedema

    Time frame: 12 months after the last liposuction surgery

    Assess the effect of liposuction on quality of life and everyday activities (RAND-36)

Other outcomes

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

    Time frame: 6 months after inclusion

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

  2. Adverse effect of liposuction

    Time frame: 12 months after last liposuction surgery

    Assess possible adverse effects of liposuction

  3. Effect of liposuction on the need for conservative treatment

    Time frame: 3 years after last liposuction surgery

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

Sponsors and collaborators

Lead sponsor

Haraldsplass Deaconess Hospital

Other

Collaborators

  • Helse Vest
  • Klinbeforsk
  • St. Olavs Hospital
  • Sykehuset Telemark
  • University Hospital of North Norway
  • University of Bergen

Registry information

Official study title

Surgical Treatment of Lipedema in Norway - a National Multicenter Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 17, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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