LipedemaNCT07878299
Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
An observational study of Lipedema and Obesity, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the total and regional body composition characteristics of women with lipedema and women without lipedema who are matched for age and body mass index, as determined by the TANITA MC-580 segmental bioelectrical impedance analysis (BIA) device. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema, Obesity, Body Mass Index
- What is being tested?
- Bioelectrical Impedance Analysis, Numeric Rating Scale and Lower Extremity Functional Scale
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult female patients diagnosed with lipedema who present to the Physical Medicine and Rehabilitation Outpatient Clinic during the study period, along with female volunteers with a similar mean BMI who are evaluated at the outpatient clinic.
Who may be able to join
- 1. Inclusion Criteria (Lipedema Group)
- Being female.
- Being between 18-65 years of age.
- Having received a diagnosis of lipedema based on clinical evaluation.
- Being willing to participate in the study and signing the written informed consent form.
- 2. Inclusion Criteria (BMI-Matched Obese Group)
Show all 11Show fewer
- Being female.
- Being between 18-65 years of age.
- Not meeting the diagnostic criteria for lipedema on clinical evaluation.
- Showing similar characteristics to the lipedema group in terms of age and BMI.
- Being willing to participate in the study and signing the written informed consent form.
Who cannot join
- Being pregnant or breastfeeding.
- Having a diagnosis of primary or secondary lymphedema.
- Having clinically advanced-stage chronic venous insufficiency, an active venous ulcer, or a history of acute deep vein thrombosis.
- Having a history of surgery or serious trauma within the last 6 months.
- Having an active infection, cellulitis, or open wound.
- Presence of edema due to congestive heart failure, advanced renal failure, or decompensated liver disease.
Show all 9Show fewer
- Having a diagnosis of active malignancy.
- Having a neurological, rheumatological, or serious musculoskeletal disease that could affect the assessment.
- Being unable to comply with study procedures or not providing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Uskudar
Istanbul, Uskudar
Feyza Yücel Assoc.Prof.
About this study
Official title: Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity: A Body Mass Index-Matched Bioelectrical Impedance Analysis Study
The aim of this study is to compare the total and regional body composition characteristics of women with lipedema and women without lipedema who are matched for age and body mass index, as determined by the TANITA MC-580 segmental bioelectrical impedance analysis (BIA) device. In addition to total fat mass and fat percentage, fat mass, fat-free mass, and muscle mass measurements of the right and left legs, right and left arms, and trunk are planned to be evaluated. From these measurements, regional distribution indicators such as the proportion of lower extremity fat mass within total body fat, the leg-to-trunk fat ratio, the leg-to-arm fat ratio, and the leg muscle-to-fat ratio will be calculated. In addition, the study aims to examine the relationships between segmental body composition characteristics and disease type and stage, disease duration, pain severity, and lower extremity function in the lipedema group.
Hypothesis: The proportion of total body fat located in the lower extremities is significantly higher in women with lipedema compared to women without lipedema matched for age and body mass index.
Read the detailed description
This cross-sectional observational study aims to evaluate body composition characteristics in women with lipedema and examine their associations with clinical symptoms and functional status. Body composition will be assessed using bioelectrical impedance analysis, including body fat percentage, muscle mass, total body water, visceral fat level, and segmental body composition parameters. Anthropometric measurements and lipedema-related clinical characteristics will also be recorded. Pain severity, lower-extremity function, and health-related quality of life will be evaluated using validated patient-reported outcome measures. The findings obtained from this study are not intended to establish the diagnosis of lipedema based solely on BIA measurement; rather, they are expected to contribute to the identification of objective and measurable body composition indicators that can support existing clinical assessment. The segmental parameters and candidate distribution indices to be identified may offer research indicators that could be validated in different samples in the future. Furthermore, demonstrating the relationship between regional fat and muscle distribution and pain and lower extremity function in women with lipedema may contribute to the development of a more comprehensive approach that can be used in the evaluation and follow-up of patients.
- Conditions
- Lipedema, Obesity, Body Mass Index, Bioelectrical Impedance Analysis
- Being tested
- Bioelectrical Impedance Analysis, Numeric Rating Scale, Lower Extremity Functional Scale, Short Form-12, Clinical Staging
- Keywords
- Lipedema, Obesity, Index
- Medical subject headings
- Lipedema, Obesity, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance AnalysisOther
Body composition will be assessed using bioelectrical impedance analysis. Total and segmental body composition parameters, including body fat mass, body fat percentage, muscle mass, and total body water, will be recorded.
Numeric Rating ScaleOther
Also called NRS
Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower Extremity Functional ScaleOther
Also called LEFS
Functional status will be assessed using the Lower Extremity Functional Scale. The total score ranges from 0 to 80, with higher scores indicating better lower extremity function and lower disability levels.
Short Form-12Other
Also called SF-12
Health-related quality of life will be assessed using the SF-12 questionnaire, including the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores. Scores range from 0 to 100, with higher scores indicating better perceived health status and quality of life.
Clinical StagingOther
Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Female patients with lipedema | Group/Cohort Description: Female patients with lipedema Receives: Other: Bioelectrical Impedance Analysis; Other: Numeric Rating Scale; Other: Lower Extremity Functional Scale; Other: Short Form-12; Other: Clinical Staging | |
| Group 2: Obese/overweight women | BMI-matched obese women Receives: Other: Bioelectrical Impedance Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the total fat mass of the two legs to total body fat mass
The ratio will be calculated by dividing the sum of the fat mass of both legs by total body fat mass, as measured using bioelectrical impedance analysis.
Measured: Baseline
Secondary outcomes (9)
Total fat mass
Total fat mass will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of fat mass in the body.
Measured: Baseline
Fat-free body mass
Fat-free body mass will be measured in kilograms using bioelectrical impedance analysis and represents total body mass excluding fat mass.
Measured: Baseline
Total and skeletal muscle mass
Total muscle mass and skeletal muscle mass will be measured in kilograms using bioelectrical impedance analysis and represent the estimated amounts of total muscle tissue and skeletal muscle tissue in the body, respectively.
Measured: Baseline
Total body water
Total body water will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of water in the body.
Measured: Baseline
Visceral fat level
Visceral fat level will be assessed using bioelectrical impedance analysis and reported as a device-generated rating reflecting the estimated amount of fat surrounding the internal abdominal organs.
Measured: Baseline
Leg-to-trunk fat ratio
The leg-to-trunk fat ratio will be calculated by dividing the sum of the fat mass of both legs by trunk fat mass, as measured using bioelectrical impedance analysis.
Measured: Baseline
Leg-to-arm fat ratio
The leg-to-arm fat ratio will be calculated by dividing the sum of the fat mass of both legs by the sum of the fat mass of both arms, as measured using bioelectrical impedance analysis.
Measured: Baseline
Leg muscle-to-fat ratio
The leg muscle-to-fat ratio will be calculated by dividing the total muscle mass of both legs by the total fat mass of both legs, as measured using bioelectrical impedance analysis.
Measured: Baseline
Right-left extremity asymmetry
Right-left extremity asymmetry will be assessed by calculating the absolute differences in fat mass and muscle mass between the right and left upper and lower extremities, as measured using bioelectrical impedance analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start20 Sep 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Feyza Nur Yücel, Assoc. Prof., Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878299
- Sponsor's protocol ID
- 33
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data generated and analyzed during this study will not be publicly shared.
Publications
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
PubMed 35730511Citaker S, Kafa N, Hazar Kanik Z, Ugurlu M, Kafa B, Tuna Z. Translation, cross-cultural adaptation and validation of the Turkish version of the Lower Extremity Functional Scale on patients with knee injuries. Arch Orthop Trauma Surg. 2016 Mar;136(3):389-95. doi: 10.1007/s00402-015-2384-6. Epub 2016 Jan 4.
PubMed 26728274Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
PubMed 15380917Gursen C, Cools J, Claes L, De Groef A, Meeus M, Spincemaille L, Pouchele F, Thomis S, Cornelissen V, Devoogdt N. Exploring quality of life and physical-physiological characteristics in obese patients with and without lipedema: insights from the LipObes study. BMC Womens Health. 2026 Jun 20. doi: 10.1186/s12905-026-04580-2. Online ahead of print.
PubMed 42321781Halk AB, Damstra RJ. First Dutch guidelines on lipedema using the international classification of functioning, disability and health. Phlebology. 2017 Apr;32(3):152-159. doi: 10.1177/0268355516639421. Epub 2016 Jul 9.
PubMed 27075680Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.
PubMed 31544340
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity: A Body Mass Index-Matched Bioelectrical Impedance Analysis Study
- ClinicalTrials.gov ID
- NCT07878299
- Acronym / sponsor ID
- 33
- Conditions
- Lipedema, Obesity, Body Mass Index, Bioelectrical Impedance Analysis
- Keywords
- Lipedema, Obesity, Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the total and regional body composition characteristics of women with lipedema and women without lipedema who are matched for age and body mass index, as determined by the TANITA MC-580 segmental bioelectrical impedance analysis (BIA) device. In addition to total fat mass and fat percentage, fat mass, fat-free mass, and muscle mass measurements of the right and left legs, right and left arms, and trunk are planned to be evaluated. From these measurements, regional distribution indicators such as the proportion of lower extremity fat mass within total body fat, the leg-to-trunk fat ratio, the leg-to-arm fat ratio, and the leg muscle-to-fat ratio will be calculated. In addition, the study aims to examine the relationships between segmental body composition characteristics and disease type and stage, disease duration, pain severity, and lower extremity function in the lipedema group.
Hypothesis: The proportion of total body fat located in the lower extremities is significantly higher in women with lipedema compared to women without lipedema matched for age and body mass index.
Detailed description
This cross-sectional observational study aims to evaluate body composition characteristics in women with lipedema and examine their associations with clinical symptoms and functional status. Body composition will be assessed using bioelectrical impedance analysis, including body fat percentage, muscle mass, total body water, visceral fat level, and segmental body composition parameters. Anthropometric measurements and lipedema-related clinical characteristics will also be recorded. Pain severity, lower-extremity function, and health-related quality of life will be evaluated using validated patient-reported outcome measures. The findings obtained from this study are not intended to establish the diagnosis of lipedema based solely on BIA measurement; rather, they are expected to contribute to the identification of objective and measurable body composition indicators that can support existing clinical assessment. The segmental parameters and candidate distribution indices to be identified may offer research indicators that could be validated in different samples in the future. Furthermore, demonstrating the relationship between regional fat and muscle distribution and pain and lower extremity function in women with lipedema may contribute to the development of a more comprehensive approach that can be used in the evaluation and follow-up of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Female patients with lipedema | – | Other: Bioelectrical Impedance Analysis, Other: Numeric Rating Scale, Other: Lower Extremity Functional Scale, Other: Short Form-12, Other: Clinical StagingGroup/Cohort Description: Female patients with lipedema |
| Group 2: Obese/overweight women | – | Other: Bioelectrical Impedance AnalysisBMI-matched obese women |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult female patients diagnosed with lipedema who present to the Physical Medicine and Rehabilitation Outpatient Clinic during the study period, along with female volunteers with a similar mean BMI who are evaluated at the outpatient clinic.
Key inclusion criteria (11 listed)
- 1. Inclusion Criteria (Lipedema Group)
- Being female.
- Being between 18-65 years of age.
- Having received a diagnosis of lipedema based on clinical evaluation.
- Being willing to participate in the study and signing the written informed consent form.
Key exclusion criteria (9 listed)
- Being pregnant or breastfeeding.
- Having a diagnosis of primary or secondary lymphedema.
- Having clinically advanced-stage chronic venous insufficiency, an active venous ulcer, or a history of acute deep vein thrombosis.
- Having a history of surgery or serious trauma within the last 6 months.
- Having an active infection, cellulitis, or open wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance AnalysisBody composition will be assessed using bioelectrical impedance analysis. Total and segmental body composition parameters, including body fat mass, body fat percentage, muscle mass, and total body water, will be recorded. | Other | Group 1: Female patients with lipedema, Group 2: Obese/overweight women |
| Numeric Rating ScaleAlso: NRSPain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). | Other | Group 1: Female patients with lipedema |
| Lower Extremity Functional ScaleAlso: LEFSFunctional status will be assessed using the Lower Extremity Functional Scale. The total score ranges from 0 to 80, with higher scores indicating better lower extremity function and lower disability levels. | Other | Group 1: Female patients with lipedema |
| Short Form-12Also: SF-12Health-related quality of life will be assessed using the SF-12 questionnaire, including the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores. Scores range from 0 to 100, with higher scores indicating better perceived health status and quality of life. | Other | Group 1: Female patients with lipedema |
| Clinical StagingLipedema stage will be determined according to clinical examination findings and established diagnostic criteria. | Other | Group 1: Female patients with lipedema |
Primary outcome
Ratio of the total fat mass of the two legs to total body fat mass
Time frame: Baseline
The ratio will be calculated by dividing the sum of the fat mass of both legs by total body fat mass, as measured using bioelectrical impedance analysis.
9 secondary outcomes
Total fat mass
Time frame: Baseline
Fat-free body mass
Time frame: Baseline
Total and skeletal muscle mass
Time frame: Baseline
Total body water
Time frame: Baseline
Visceral fat level
Time frame: Baseline
Leg-to-trunk fat ratio
Time frame: Baseline
Leg-to-arm fat ratio
Time frame: Baseline
Leg muscle-to-fat ratio
Time frame: Baseline
Right-left extremity asymmetry
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 35730511Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- Background: PubMed 26728274Citaker S, Kafa N, Hazar Kanik Z, Ugurlu M, Kafa B, Tuna Z. Translation, cross-cultural adaptation and validation of the Turkish version of the Lower Extremity Functional Scale on patients with knee injuries. Arch Orthop Trauma Surg. 2016 Mar;136(3):389-95. doi: 10.1007/s00402-015-2384-6. Epub 2016 Jan 4.
- Background: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Background: PubMed 15380917Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
- Background: PubMed 42321781Gursen C, Cools J, Claes L, De Groef A, Meeus M, Spincemaille L, Pouchele F, Thomis S, Cornelissen V, Devoogdt N. Exploring quality of life and physical-physiological characteristics in obese patients with and without lipedema: insights from the LipObes study. BMC Womens Health. 2026 Jun 20. doi: 10.1186/s12905-026-04580-2. Online ahead of print.
- Background: PubMed 27075680Halk AB, Damstra RJ. First Dutch guidelines on lipedema using the international classification of functioning, disability and health. Phlebology. 2017 Apr;32(3):152-159. doi: 10.1177/0268355516639421. Epub 2016 Jul 9.
- Background: PubMed 31544340Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.
- Individual participant dataSharing planned: No. The individual participant data generated and analyzed during this study will not be publicly shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feyza Nur Yücel, Assoc. Prof. principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Obesity, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel, Assoc. Prof. (2165422000 ext. +90, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of the total fat mass of the two legs to total body fat mass (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07878299, which also lists 8 linked publications.
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 16 Oct 2026.