The National Lipedema 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.

Conditions

• Lipedema

Interventions

PROCEDURE

Liposuction early

Liposuction 6-9 months after inclusion

PROCEDURE

Liposuction late

Liposuction 18-21 months after inclusion

OTHER

Standard conservative treatment

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

OTHER

Standard conservative treatment with Intermittent Pneumatic Compression (IPC)

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

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• University of Bergen

  collaborator OTHER

• Klinbeforsk

  collaborator OTHER

• Helse Vest

  collaborator OTHER

• Haraldsplass Deaconess Hospital

  lead OTHER

Principal Investigators

• Hildur Skuladottir, PhD · Haraldsplass Deaconess Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-11

Primary Completion

2026-10-31

Completion

2027-12-31

Countries

• Norway

Study Locations