- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05861583
Evaluation of Lipoedema Tissue Transcriptome
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tobias Kisch, MD
- Phone Number: 004945150040512
- Email: tobias.kisch@uni-luebeck.de
Study Locations
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-
Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- Recruiting
- University of Schleswig-Holstein
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Contact:
- Tobias Kisch, MD
- Phone Number: 004945150040512
- Email: tobias.kisch@uni-luebeck.de
-
Principal Investigator:
- Tobias Kisch, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Inflammation in region of interest, HIV, Hepatitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lipohypertrophy
Active Comparator Tissue from healthy patients with lipohypertrophy,
|
fat tissue sample collected while cosmetical liposuction
|
Lipoedema mild stage
Experimental Tissue from lipoedema patients with mild stage (stage 1)
|
lipoedema tissue sample (stage 1) collected while medical liposuction
|
Lipoedema moderate stage
Experimental Tissue from lipoedema patients with moderate stage (stage 2)
|
lipoedema tissue sample (stage 2) collected while medical liposuction
|
Lipoedema severe stage
Experimental Tissue from lipoedema patients with severe stage (stage 3)
|
lipoedema tissue sample (stage 3) collected while medical liposuction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in RNA-Expression pattern
Time Frame: 1 day
|
Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lipo2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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