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LipedemaNCT05739279

Sarcopenia and Related Factors in Lipedema

An observational study of Lipedema and Sarcopenia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lipedema, Sarcopenia, Musculoskeletal Diseases
What is being tested?
STAR-Sonographic Thigh Adjustment Ratio, Hand Grip Strength and Chair Stand Test
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 31 Aug 2026
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 to 85 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Descriptive, cross-sectional, case-control

Who may be able to join

  • 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

Who cannot join

  • 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, malignancies, 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

Trial locations and contacts

1 site in 1 country.

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

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Sarcopenia and Associated Factors in Patients With Lipedema

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.

Being tested
STAR-Sonographic Thigh Adjustment Ratio, Hand Grip Strength, Chair Stand Test, 6 Meter Gait Speed
Keywords
Lipedema, Sarcopenia, Musculoskeletal Diseases
Medical subject headings
Lipedema, Sarcopenia, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STAR-Sonographic Thigh Adjustment RatioDiagnostic test

    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.

  • Hand Grip StrengthDiagnostic test

    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.

  • Chair Stand TestDiagnostic 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.

  • 6 Meter Gait SpeedDiagnostic test

    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.

Study groups in NCT05739279
Study groupRoleWhat they receive
Lipedema GroupPatients 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.
Receives: Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Chair Stand Test; Diagnostic Test: 6 Meter Gait Speed
Control GroupThose 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.
Receives: Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Chair Stand Test; Diagnostic Test: 6 Meter Gait Speed

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Day 1

Secondary outcomes (1)
  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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Aug 2026

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05739279
Sponsor's protocol ID
7416-GOA
Status last verified
Aug 2026
First submitted
12 Feb 2023
Last updated
2 Sep 2026
Results posted
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lipedema and Sarcopenia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 2026. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

STAR-Sonographic Thigh Adjustment Ratio (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Sep 2026.

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