Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05739279 |
| Other study ID # |
7416-GOA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Dokuz Eylul University |
| Contact |
Nihan Erdinc Gunduz, M.D. |
| Phone |
+905063992614 |
| Email |
nihanerdinc[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
