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
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.
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.
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 →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.
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.
Exclusion Criteria:
Active Comparator Tissue from healthy patients with lipohypertrophy,
Other: fat tissue
Experimental Tissue from lipoedema patients with mild stage (stage 1)
Other: lipoedema tissue (stage 1)
Experimental Tissue from lipoedema patients with moderate stage (stage 2)
Other: lipoedema tissue (stage 2)
Experimental Tissue from lipoedema patients with severe stage (stage 3)
Other: lipoedema tissue (stage 3)
fat tissue sample collected while cosmetical liposuction
lipoedema tissue sample (stage 1) collected while medical liposuction
lipoedema tissue sample (stage 2) collected while medical liposuction
lipoedema tissue sample (stage 3) collected while medical liposuction
Differences in RNA-Expression pattern
Differences in RNA-Expression pattern between lipoedema tissue and lipohypertrophy tissue
Time frame: 1 day
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.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
University Hospital Schleswig-Holstein →