The National Lipedema Study

Last updated: March 5, 2024
Sponsor: Haraldsplass Deaconess Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard conservative treatment with Intermittent Pneumatic Compression (IPC)

Liposuction early

Liposuction late

Clinical Study ID

NCT05284266
239087
  • Ages 20-65
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 220
Treatment Group(s): 4
Primary Treatment: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
Phase:
Study Start date:
March 11, 2022
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Haraldsplass Deaconess Hospital

    Bergen, 5009
    Norway

    Active - Recruiting

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