ClinicalTrials.gg
CompletedNCT05739279Updated Sep 2, 2026

Sarcopenia and Related Factors in Lipedema

An observational study in Lipedema, Sarcopenia and Musculoskeletal Diseases, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Dokuz Eylul University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
102
Ages
18 Years to 85 Years
Sex
Female
01

Study summary

Lipedema is a common disease of subcutaneous adipose tissue. The most common complaint of patients with swelling in the affected extremity is pain. In addition, patients with lipedema may experience conditions that can greatly affect the health and quality of life of the individual, such as loss of muscle strength and exercise capacity, and deterioration in activity levels of daily living. It is still unknown whether the decrease in muscle strength in patients with lipedema is part of this condition or whether decreased activity levels lead to decreased muscle strength.

Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. The relationship between muscle weakness and sarcopenia in patients with lipedema has not been investigated before. Early recognition of possible sarcopenia and functional limitations in these patients may be important to increase the ability of patients to participate in physical activity as part of their conservative management.

There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. The aim of this study is to evaluate patients with a diagnosis of lipedema in terms of sarcopenia. In addition, the relationship between sarcopenia and age, body mass index, exercise frequency, lipedema type, and stage will be investigated in patients diagnosed with lipedema.

Read the detailed description

Lipedema is a chronic progressive condition in women characterized by a disproportionate increase in subcutaneous adipose tissue, accompanied by pain in the legs and sometimes the arms. It was first described in the 1940s and was expressed as fluid accumulation in the wide legs and legs due to subcutaneous fat deposition in the hips and lower extremities. Lipedema is characterized by bilateral enlargement from the hip to the ankle, often sparing the foot, due to abnormal deposition of subcutaneous fat, often with mild edema. The fact that many patients have pain and sensitivity has led to the use of the term painful fat syndrome. The disease usually begins at or just after puberty. Although some lipoedema patients are obese or overweight, the patients often have a normal appearance from the waist up and there is a disproportionate appearance between their trunk and lower extremities. Protection of the hands and feet is typical. This disease, which almost always affects women, has rarely been defined in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although its prevalence is not known exactly, it is thought to be a much more common disease than expected because it is confused with other diseases such as obesity, venous insufficiency, and lymphedema and is a frequently missed diagnosis. Although the results of the studies vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women affected by this disease.

The pathophysiology of lipoedema is multifactorial, and causes such as increased permeability and capillary fragility due to microangiopathy in adipose tissue, adipocyte necrosis due to hypoxia, and macrophage migration are prioritized. In addition, lymphatic drainage through HIF-1 (hypoxia-inducible factor 1), VEGF (Vascular Endothelial Growth Factor), and FFA (Free Fatty Acid) increases and endothelial barrier function are affected, resulting in impaired vascular circulation due to fluid extravasation and fat accumulation. are held. Estrogen has effects on peripheral and central mechanisms and fat metabolism. The decrease in lipolysis in the femoral region and the increase in lipedema during periods of hormonal changes such as pregnancy, menopause, and oral contraceptive use suggest that hormonal mechanisms are effective on the disease. Preoptic and arcuate nuclei in the hypothalamus; It is involved in lipid mobilization and distribution of white adipose tissue and forms a pathway through ER α (estrogen receptor alpha) and its mediator CART (Cocaine and Amphetamine Regulatory Transcript). Disruption in this regulation pathway also results in regional adipose tissue deposition. There is a family history of 15-64% of the patients, and genetics is thought to be significantly effective. Pedigree studies indicate X-dominant or autosomal-dominant inheritance.

Lipedema usually presents with bilateral extremity swelling that begins in the post-adolescent period, is progressive, does not respond to diet and exercise, does not improve with elevation, and is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. Typically, the hands or feet are not involved, although this may involve the hip and gluteal region. On examination, the skin is often of normal color and texture, and oily hypertrophy may feel soft and pasty. Bruises caused by minor traumas can be observed during the examination. It does not leave pitting after long-term pressure is applied with the finger, and the Stemmer sign, which is observed by compressing the skin on the dorsum of the foot, is negative. Evaluation of these two findings is important in differentiating it from lymphedema. Lipedema consists of 5 major types:

  • Type 1 pelvis, gluteal region, and hips,
  • Type 2 extending from the gluteal region to the knees and with fat folds in the inner parts of the knees,
  • Type 3 extending from the gluteal region to the ankles,
  • Type 4 located in arms,
  • Type 5 is defined as the presence of isolated swelling in the lower part of the legs.

Types 1-3 are the 3 most common. Lipedema can be seen in 3 stages. In stage 1, the skin surface is normal, the subcutaneous tissue is enlarged, and small nodules are present on palpation. In stage 2, the skin surface is irregular, and large fat nodules are seen. In stage 3, the skin contour is lobulated due to the increase in adipose tissue, and large nodules and deformities are observed. Some sources state the form of lipedema accompanied by lymphedema is stage 4, and this is called lipo lymphedema.

The diagnosis is made clinically, and the history and physical examination can be supported by assistive imaging techniques. The skin and subcutaneous tissue can be examined qualitatively and quantitatively by ultrasonography, computed tomography, or magnetic resonance imaging.

Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. It is a harbinger of physical fragility and limitation of movement. Muscle wasting is mainly due to the loss of type II muscle fibers, and progressive motor neuron loss is thought to be the primary underlying factor. Anterior thigh muscles atrophy earlier and loss of anterior thigh muscle function may therefore be a precursor finding.

Experts in the sarcopenia special interest group (ISarcoPRM) under the umbrella of the International Society for Physical and Rehabilitation Medicine (ISPRM) have developed a new algorithm based on regional measurements and functional assessments of the anterior thigh muscle, which is initially and most frequently affected in sarcopenia.

The iSarcoPRM has proposed a new measurement that uses anterior thigh muscle measurements for early assessment and rapid diagnosis of low muscle mass and confirmation of sarcopenia. Accordingly, STAR- (sonographic thigh adjustment ratio) sonographic thigh adjustment ratio is found by dividing anterior thigh muscle thickness by body mass index. Using two standard deviation values of healthy young adults, the threshold values for the sonographic thigh fit ratio were found to be 1.4 and 1.0 for male and female subjects, respectively.

As sarcopenia diagnostic criteria;

  • STAR- (sonographic thigh adjustment ratio) sonographic thigh adjustment ratio below 1.4 and 1.0 for men and women, respectively
  • For muscle strength measurement, hand grip strength is below 32 and 19 kg for men and women, respectively
  • It is recommended that the 5-repeat stand-up test (CST (chair stand test)) be longer than 12 seconds.

It has been suggested that walking speed (6 meters) ≤0.8 m/s or inability to get up from a chair without support (limited movement) should be the primary outcome, not part of the diagnostic criteria.

Although pain is the most common complaint of patients with lipoedema along with swelling in the involved extremity, conditions such as loss of muscle strength and exercise capacity, and deterioration in daily life activity levels, can greatly affect the health and quality of life of the individual, can also be seen.

These patients have thickening of the lower extremities beginning in adolescence; limited exercise, dietary changes, or swelling of the affected extremities; they have a medical history that includes limitations in functionality such as fatigue, family history, inability to work, and loss of activity level.

It is still unknown whether the decrease in muscle strength in patients with lipoedema is part of this condition or whether decreased activity levels lead to decreased muscle strength. The relationship between muscle weakness and sarcopenia in these patients has not been investigated before. Early recognition of possible sarcopenia and functional limitations in this patient group may be important to increase the ability of patients to participate in physical activity as a part of conservative management. There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. This study aims to evaluate patients with a diagnosis of lipedema in terms of sarcopenia.

02

Conditions studied

  • Lipedema
  • Sarcopenia
  • Musculoskeletal Diseases

Keywords

  • Lipedema
  • Sarcopenia
  • Musculoskeletal Diseases
03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 102 is above the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Descriptive, cross-sectional, case-control

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

  • between the ages of 18-85
  • with a diagnosis of lipoedema
  • who agreed to participate in the study
  • having a sociocultural level suitable for participation in the study
  • healthy volunteers in a similar age group for the control group

Exclusion criteria

Exclusion Criteria:

  • with chronic venous insufficiency and/or lymphedema
  • with Parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis, major depression, neuromuscular diseases, history of major orthopedic surgery, severe hip/knee osteoarthritis, rheumatological diseases, , advanced heart/liver/renal failure, visual impairment, and vestibular diseases, and those who use any assistive device to walk
  • who are illiterate and have cognitive impairment that will prevent them from giving written consent will not be included in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • Lipedema Group

    Patients between the ages of 18-85, diagnosed with lipedema, accepted to participate in the study, and at the appropriate sociocultural level to participate in the study are included in this group.

    Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio · Diagnostic Test: Hand Grip Strength · Diagnostic Test: Chair Stand Test · Diagnostic Test: 6 Meter Gait Speed

  • Control Group

    Those between the ages of 18-85, in an age group similar to the lipoedema group, who agreed to participate in the study, and who were at the appropriate sociocultural level to participate in the study are included in this group.

    Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio · Diagnostic Test: Hand Grip Strength · Diagnostic Test: Chair Stand Test · Diagnostic Test: 6 Meter Gait Speed

Interventions

  • Diagnostic testSTAR-Sonographic Thigh Adjustment Ratio

    With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.

  • Diagnostic testHand Grip Strength

    Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.

  • Diagnostic testChair Stand Test

    For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.

  • Diagnostic test6 Meter Gait Speed

    For walking speed measurements, patients will be asked to stand with both feet touching the starting line and walk at their normal speed on a 6-meter track after the command. The time between the start and end will be measured with a stopwatch and converted to meters/second. Three consecutive measurements will be made for both and average values will be taken for the analyses.

06

What researchers measure

Primary outcomes

  1. STAR-Sonographic Thigh Adjustment Ratio

    With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.

    Time frame: Day 1

  2. Hand Grip Strength

    Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.

    Time frame: Day 1

  3. Chair Stand Test

    For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.

    Time frame: Day 1

Secondary outcomes

  1. 6 Meter Gait Speed

    For walking speed measurements, patients will be asked to stand with both feet touching the starting line and walk at their normal speed on a 6-meter track after the command. The time between the start and end will be measured with a stopwatch and converted to meters/second. Three consecutive measurements will be made for both and average values will be taken for the analyses

    Time frame: Day 1

07

Study locations

1 site
  • Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
    Izmir, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Dec 2025, 35 months.

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

Registered
Feb 12, 2023
First posted
Feb 22, 2023
StartActual
Jan 1, 2023
Primary completionActual
Dec 31, 2025
CompletionActual
Aug 31, 2026
Last update
Sep 2, 2026
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 Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05739279
Responsible party
Nihan ERDINC GUNDUZ (Assistant Professor, Dokuz Eylul University) — Principal investigator
First posted
Feb 22, 2023
Start date
Jan 1, 2023
Primary completion
Dec 31, 2025
Completion
Aug 31, 2026
Last update
Sep 2, 2026

Study contacts

Nihan Erdinc Gunduz, M.D.
study director · Dokuz Eylul University

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. 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