The National Lipedema Study

Lipedema Clinical Trial

Official title:

Surgical Treatment of Lipedema in Norway - a National Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284266
• Other study ID #: 239087
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Haraldsplass Deaconess Hospital
• Contact: Aslaug Drotningsvik, PhD
• Phone: 55978626
• Email: lipodem[@]haraldsplass.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipedema

Intervention

Procedure:
• Liposuction early
Liposuction 6-9 months after inclusion
• 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
• Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess Hospital	Bergen

Sponsors (7)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital	Helse Vest, Klinbeforsk, St. Olavs Hospital, Sykehuset Telemark, University Hospital of North Norway, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	6 months after inclusion
Other	Adverse effect of liposuction	Assess possible adverse effects of liposuction	12 months after last liposuction surgery
Other	Effect of liposuction on the need for conservative treatment	Assess whether having undergone liposuction changes the need for conservative treatment.	3 years after last liposuction surgery
Primary	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).	12 months after the last liposuction surgery
Secondary	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)	12 months after the last liposuction surgery