NCT05861583

Brief Summary

Lipoedema is a chronic painful disease with a fat distribution disorder affecting women. It is probably aggravated by hormonal changes. It is also discussed that a genetical predisposition might be a risk factor for developing lipoedema. The mechanisms leading to lipoedema are mostly unknown. The aim of this study is to identify molecular mechanisms and changes of the RNA-Expression pattern causing lipoedema by comparing the transcriptome of subcutaneous tissue of lipoedema patients vs. healthy subcutaneous tissue.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

May 6, 2023

Last Update Submit

July 25, 2023

Conditions

Lipedema

Keywords

lipoedematranscriptomicsfat tissue

Outcome Measures

Primary Outcomes (1)

  • Differences in RNA-Expression pattern

    Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue

    1 day

Study Arms (4)

Lipohypertrophy

Active Comparator Tissue from healthy patients with lipohypertrophy,

Other: fat tissue

Lipoedema mild stage

Experimental Tissue from lipoedema patients with mild stage (stage 1)

Other: lipoedema tissue (stage 1)

Lipoedema moderate stage

Experimental Tissue from lipoedema patients with moderate stage (stage 2)

Other: lipoedema tissue (stage 2)

Lipoedema severe stage

Experimental Tissue from lipoedema patients with severe stage (stage 3)

Other: lipoedema tissue (stage 3)

Interventions

fat tissueOTHER

fat tissue sample collected while cosmetical liposuction

Lipohypertrophy
lipoedema tissue (stage 1)OTHER

lipoedema tissue sample (stage 1) collected while medical liposuction

Lipoedema mild stage
lipoedema tissue (stage 2)OTHER

lipoedema tissue sample (stage 2) collected while medical liposuction

Lipoedema moderate stage
lipoedema tissue (stage 3)OTHER

lipoedema tissue sample (stage 3) collected while medical liposuction

Lipoedema severe stage

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consent-capable female patients ≥18 years of age with either lipohypertrophy or lipoedema

You may qualify if:

  • Lipohypertrophy: tissue from healthy patients (n=20): Consent-capable female patients ≥18 years of age with lipohypertrophy
  • Lipoedema milde stage: tissue from Lipoedema patients with mild stage 1 (n=20): Consent-capable female patients ≥18 years of age with Lipoedema (Stage 1)
  • Lipoedema moderate stage: tissue from Lipoedema patients with moderate stage 2 (n=20): Consent-capable female patients ≥18 years of age with Lipoedema (Stage 2)
  • Lipoedema severe stage: tissue from Lipoedema patients with severe stage 3 (n=20): Consent-capable female patients ≥18 years of age with Lipoedema (Stage 3)

You may not qualify if:

  • Inflammation in region of interest, HIV, Hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Related Publications (1)

  • Streubel MK, Baumgartner A, Meier-Vollrath I, Frambach Y, Brandenburger M, Kisch T. Transcriptomics of Subcutaneous Tissue of Lipedema Identified Differentially Expressed Genes Involved in Adipogenesis, Inflammation, and Pain. Plast Reconstr Surg Glob Open. 2024 Nov 8;12(11):e6288. doi: 10.1097/GOX.0000000000006288. eCollection 2024 Nov.

    PMID: 39525887DERIVED

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Tobias Kisch, MD

CONTACT

004945150040512tobias.kisch@uni-luebeck.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 17, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

DE(1)