ClinicalTrials.gg
Status unknownNCT05861583Updated Jul 27, 2023

Evaluation of Lipoedema Tissue Transcriptome

An observational study in Lipedema, sponsored by University Hospital Schleswig-Holstein. Status unknown at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by University Hospital Schleswig-Holstein · Observational

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Lipoedema is a fat distribution disorder affecting mostly women. This chronic disease is characterized by painful fatty tissue accumulating especially at the limbs. The aetiopathogenesis of this disease is unsure. It is observed that a familial predisposition might increase the risk of developing lipoedema. Hormonal variations during puberty, pregnancy or climacteric period are also discussed as main factor for lipoedema. Molecular and genetical changes are rarely identified. The aim of this study is to identify changes in the expression pattern of fat cells causing lipoedema. One possibility to medicate this disease is to reduce the subcutaneous fatty tissue by liposuction. While this surgical procedure, a tumescent solution for reducing bleeding and pain is used. This study is also trying to identify the effect of tumescent solution to fatty tissue.

This trial is an explorative study using excised tissue by surgery to compare the gene expression pattern of subcutaneous tissue of lipoedema patients to healthy subcutaneous tissue. Therefore, lipoedema patients of mild stage, moderate stage and severe stage as well as healthy patients with lipohypertrophy as control group are included to the study. The participation was on a voluntary basis. Only patients who reached the age of majority and who are able to consent were included.

The study group patients are characterized by the typical, symmetrical and painful fat distribution especially at the limbs. The aim of the surgical treatment via liposuction of lipoedema patients is to reduce the fatty tissue, which is causing the development of oedema, the persistent pain and the formation of haematoma. The control group patients are determined by having a healthy subcutaneous fatty tissue, which was surgical reduced caused by cosmetical effects. The subcutaneous tissue therefore was reduced via liposuction following the standardised operation procedures. Starting the procedure, a small native tissue sample is collected without any additional invasive procedure. After installing a tumescent anaesthetic solution containing epinephrine and local anaesthetics subcutaneous the liposuction will be performed. The liposuction is done in power assisted liposuction technique. An additional sample of liposuctioned fat tissue treated with tumescent solution will be collected. The RNA-Expression pattern of the fatty tissue will be analysed by performing a NGS-Analysis. Changes of the RNA-Expression of lipoedema of different stages compared to normal fatty tissue will be detected. Further the effect of the intra-surgical used tumescent solution on fat cells can be detected by comparing native and treated tissue samples.

Another aim of the study is to collect data concerning anamnestic aspects, symptoms and factors possibly leading to the development and progress of the disease. These data will be analysed to identify risk factors for lipoedema.

02

Conditions studied

  • Lipedema

Browse trials for

Keywords

  • lipoedema
  • transcriptomics
  • fat tissue
03

In context

Lipedema

83 studies on the registry are indexed under Lipedema; 31 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Lipohypertrophy: tissue from healthy patients (n=20): Consent-capable female patients ≥18 years of age with lipohypertrophy
  2. 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)
  3. 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)
  4. 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)

Exclusion criteria

Exclusion Criteria:

  • Inflammation in region of interest, HIV, Hepatitis
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherfat tissue

    fat tissue sample collected while cosmetical liposuction

  • Otherlipoedema tissue (stage 1)

    lipoedema tissue sample (stage 1) collected while medical liposuction

  • Otherlipoedema tissue (stage 2)

    lipoedema tissue sample (stage 2) collected while medical liposuction

  • Otherlipoedema tissue (stage 3)

    lipoedema tissue sample (stage 3) collected while medical liposuction

06

What researchers measure

Primary outcomes

  1. Differences in RNA-Expression pattern

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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • University of Schleswig-Holstein
    Lübeck, Schleswig-Holstein 23538, Germany
    Recruiting
08

References and documents

Publications

  • 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. PubMed 39525887 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Dec 2023, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2023
First posted
May 17, 2023
StartActual
Jan 1, 2023
Primary completionEst.
Dec 1, 2023
CompletionEst.
Mar 1, 2024
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05861583
Collaborators
Hanse-Klinik, Fachklinik für Liposuktion, Lübeck, Praxisklinik Kronshagen, Kiel-Kronshagen
Responsible party
Tobias Kisch (Principal Investigator, University Hospital Schleswig-Holstein) — Principal investigator
First posted
May 17, 2023
Start date
Jan 1, 2023
Primary completion
Dec 1, 2023 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Tobias Kisch, MD
Contact
tobias.kisch@uni-luebeck.de
004945150040512

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion