LipedemaNCT05861583
Evaluation of Lipoedema Tissue Transcriptome
An observational study of Lipedema, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- fat tissue, lipoedema tissue (stage 1) and lipoedema tissue (stage 2)
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Consent-capable female patients ≥18 years of age with either lipohypertrophy or lipoedema
Who may be able to join
- 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)
Who cannot join
- Inflammation in region of interest, HIV, Hepatitis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Tobias Kisch, MD, 004945150040512, tobias.kisch@uni-luebeck.de
Tobias Kisch, MD
About this study
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.
- Conditions
- Lipedema
- Being tested
- fat tissue, lipoedema tissue (stage 1), lipoedema tissue (stage 2), lipoedema tissue (stage 3)
- Keywords
- lipoedema, transcriptomics, fat tissue
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat tissueOther
fat tissue sample collected while cosmetical liposuction
lipoedema tissue (stage 1)Other
lipoedema tissue sample (stage 1) collected while medical liposuction
lipoedema tissue (stage 2)Other
lipoedema tissue sample (stage 2) collected while medical liposuction
lipoedema tissue (stage 3)Other
lipoedema tissue sample (stage 3) collected while medical liposuction
| Study group | Role | What they receive |
|---|---|---|
| Lipohypertrophy | Active Comparator Tissue from healthy patients with lipohypertrophy, Receives: Other: fat tissue | |
| Lipoedema mild stage | Experimental Tissue from lipoedema patients with mild stage (stage 1) Receives: Other: lipoedema tissue (stage 1) | |
| Lipoedema moderate stage | Experimental Tissue from lipoedema patients with moderate stage (stage 2) Receives: Other: lipoedema tissue (stage 2) | |
| Lipoedema severe stage | Experimental Tissue from lipoedema patients with severe stage (stage 3) Receives: Other: lipoedema tissue (stage 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in RNA-Expression pattern
Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jan 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Hanse-Klinik, Fachklinik für Liposuktion, Lübeck, Praxisklinik Kronshagen, Kiel-Kronshagen
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861583
- Sponsor's protocol ID
- Lipo2023
- Status last verified
- Jul 2023
- First submitted
- 6 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lipoedema Tissue Transcriptome
- ClinicalTrials.gov ID
- NCT05861583
- Acronym / sponsor ID
- Lipo2023
- Conditions
- Lipedema
- Keywords
- lipoedema, transcriptomics, fat tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Hanse-Klinik, Fachklinik für Liposuktion, Lübeck, Praxisklinik Kronshagen, Kiel-Kronshagen
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lipohypertrophy | – | Other: fat tissueActive Comparator Tissue from healthy patients with lipohypertrophy, |
| Lipoedema mild stage | – | Other: lipoedema tissue (stage 1)Experimental Tissue from lipoedema patients with mild stage (stage 1) |
| Lipoedema moderate stage | – | Other: lipoedema tissue (stage 2)Experimental Tissue from lipoedema patients with moderate stage (stage 2) |
| Lipoedema severe stage | – | Other: lipoedema tissue (stage 3)Experimental Tissue from lipoedema patients with severe stage (stage 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Consent-capable female patients ≥18 years of age with either lipohypertrophy or lipoedema
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Inflammation in region of interest, HIV, Hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fat tissuefat tissue sample collected while cosmetical liposuction | Other | Lipohypertrophy |
| lipoedema tissue (stage 1)lipoedema tissue sample (stage 1) collected while medical liposuction | Other | Lipoedema mild stage |
| lipoedema tissue (stage 2)lipoedema tissue sample (stage 2) collected while medical liposuction | Other | Lipoedema moderate stage |
| lipoedema tissue (stage 3)lipoedema tissue sample (stage 3) collected while medical liposuction | Other | Lipoedema severe stage |
Primary outcome
Differences in RNA-Expression pattern
Time frame: 1 day
Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 39525887Streubel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Kisch, MD (004945150040512, tobias.kisch@uni-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in RNA-Expression pattern (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.