The National Lipedema Study

Haraldsplass Deaconess Hospital

Status: Active, not recruiting

Conditions: Lipedema

Treatments: Other: Standard conservative treatment; Procedure: Liposuction early; Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC); Procedure: Liposuction late

Study type: Interventional

Funder types: Other

Identifiers

NCT05284266

239087

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

Standard conservative treatment

Active Comparator group

Description:

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

Treatment:

Other: Standard conservative treatment

Standard treatment plus additional lymphedema treatment

Experimental group

Description:

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)

Treatment:

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

Surgical group: Liposuction

Experimental group

Description:

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

Treatment:

Procedure: Liposuction early

Surgical group: Control

Active Comparator group

Description:

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

Treatment:

Procedure: Liposuction late