Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05861583
Other study ID # Lipo2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date March 1, 2024

Study information

Verified date July 2023
Source University Hospital Schleswig-Holstein
Contact Tobias Kisch, MD
Phone 004945150040512
Email tobias.kisch@uni-luebeck.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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: - Inflammation in region of interest, HIV, Hepatitis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fat tissue
fat tissue sample collected while cosmetical liposuction
lipoedema tissue (stage 1)
lipoedema tissue sample (stage 1) collected while medical liposuction
lipoedema tissue (stage 2)
lipoedema tissue sample (stage 2) collected while medical liposuction
lipoedema tissue (stage 3)
lipoedema tissue sample (stage 3) collected while medical liposuction

Locations

Country Name City State
Germany University of Schleswig-Holstein Lübeck Schleswig-Holstein

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Schleswig-Holstein Hanse-Klinik, Fachklinik für Liposuktion, Lübeck, Praxisklinik Kronshagen, Kiel-Kronshagen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in RNA-Expression pattern Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue 1 day
See also
  Status Clinical Trial Phase
Completed NCT04492046 - Complex Decongestive Applications in Patients With Lipedema
Completed NCT04643392 - Physiotherapy Applications in Upper Extremity Lipedema
Recruiting NCT05464927 - Visualizing Vascular Mechanisms of Lipedema
Completed NCT02907411 - Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) N/A
Completed NCT06238791 - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Completed NCT03758651 - Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study
Completed NCT03710798 - Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema N/A
Not yet recruiting NCT04166084 - Trunk Stabilization Exercises at Lipoedema Patients N/A
Recruiting NCT05628948 - Vascular Lab Resource (VLR) Biorepository
Not yet recruiting NCT05944796 - Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema N/A
Completed NCT05616962 - Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema N/A
Active, not recruiting NCT04632810 - Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema N/A
Recruiting NCT05284266 - The National Lipedema Study N/A
Active, not recruiting NCT06338059 - Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
Completed NCT04076891 - Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease Phase 2
Completed NCT03492840 - Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease Phase 2
Recruiting NCT02838277 - Insight Into Subcutaneous Adipose Tissue Disorders N/A
Completed NCT05966779 - Physical Therapy in Lipedema Surgery
Recruiting NCT05488977 - The Effects of Endurance Training on Lipedema N/A
Completed NCT04213989 - Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling) N/A