LipedemaLIP-HYPNCT07808242
Joint Hypermobility and Associated Factors in Patients With Lipedema
An observational study of Lipedema and Hypermobility, Joint, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to determine the prevalence of joint hypermobility in female patients with lipedema compared to healthy volunteers. Additionally, the study investigates how the presence of hypermobility in lipedema patients relates to the clinical and ultrasonographic stage of the disease… 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, Hypermobility, Joint
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Apr 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lipedema Group: Female patients, aged between 18 and 65 years, who were clinically diagnosed with lipedema based on detailed physical examination and clinical assessments. The participants were evaluated and recruited at the Dokuz Eylul University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic. Control Group: Healthy female volunteers, aged between 18 and 65 years, who were strictly matched to the lipedema group in terms of age and Body Mass Index (BMI).
Who may be able to join
- For Lipedema Group:
- Aged between 18-65 years. Diagnosed with lipedema. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
- For Control Group:
- Aged between 18-65 years. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
Who cannot join
- For Lipedema Group:
- Uncontrolled thyroid dysfunction. Chronic venous insufficiency and/or lymphedema (Stage 4 lipedema). Acute or chronic renal failure. Heart failure. Active cancer or ongoing cancer treatment. Presence of neurological disease. Presence of rheumatological disease. History of liposuction or major surgery for lipedema within the last 6 months. Visual or hearing impairment severe enough to affect study compliance. Illiteracy or cognitive impairment preventing the ability to give written informed consent.
- For Control Group:
- Previous diagnosis of lipedema, lymphedema, chronic venous insufficiency. History of rheumatologic, neurologic, endocrinologic, or cardiovascular diseases.
- Uncontrolled thyroid dysfunction. History of acute or chronic renal failure, heart failure, active cancer, or ongoing cancer treatment.
- Orthopedic problems affecting lower extremities, trauma, or history of liposuction/major surgery within the last 6 months.
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- Regular use of medications that may affect pain threshold (e.g., systemic corticosteroids, antidepressants, anticonvulsants, etc.).
- Physical barriers affecting pain assessment (algometry, VAS) or postural observation (e.g., severe vision/hearing loss, local skin lesions, amputation, etc.).
- Cognitive impairment or lack of literacy preventing written informed consent. Psychiatric illness preventing compliance with the study process or communication problems affecting cooperation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Faculty of Medicine Hospital
Izmir, 35330
About this study
Official title: Joint Hypermobility and Associated Factors in Patients With Lipedema: Turkish Population Data
The aim of this observational study is to determine the prevalence of joint hypermobility in female patients with lipedema compared to healthy volunteers. Additionally, the study investigates how the presence of hypermobility in lipedema patients relates to the clinical and ultrasonographic stage of the disease, regional pain severity, pain sensitivity, postural status (such as genu valgum and foot overpronation), quality of life, and physical activity levels. The study includes 65 female patients clinically diagnosed with lipedema and 65 healthy female volunteers matched for age and body mass index.
Read the detailed description
Study Overview and Design This research is designed as a cross-sectional, case-control observational study to investigate the prevalence of joint hypermobility in female patients with lipedema. The study cohort is divided into two matched groups: female patients clinically diagnosed with lipedema and a control group of healthy female volunteers strictly matched for age and Body Mass Index (BMI).
Primary and Secondary Objectives The primary objective of this study is to evaluate and compare the prevalence of generalized joint hypermobility (GJH) between the lipedema group and the healthy control group using the validated Beighton Scoring System.
The secondary objective focuses exclusively on the lipedema cohort to analyze the potential biomechanical and clinical impacts of hypermobility. It aims to determine the relationship between hypermobility status and various clinical parameters, including regional pain severity, pressure pain thresholds, lower extremity postural deviations, subcutaneous tissue thickness, and overall health-related quality of life.
Clinical Evaluations and Outcome Measures:
- Lipedema Staging and Ultrasonography: Patients undergo clinical staging (Stages 1 to 3) and typing (Types I to V) based on the anatomical distribution of the pathological adipose tissue. Subcutaneous adipose tissue thickness is measured bilaterally using a 7-11 MHz linear ultrasound probe at 6-8 cm proximal to the medial malleolus.
- Joint Hypermobility: Assessed globally using the Beighton Score. A threshold score of 5 or higher out of 9 is utilized to indicate the presence of generalized joint hypermobility.
- Pain Assessment: Evaluated through two distinct methods. Subjective pain intensity is recorded using a Visual Analog Scale (VAS, 0-10) across six bilateral anatomical regions (entire leg, thigh, knee, calf, ankle, and foot sole). Objective pain sensitivity is measured via pressure pain thresholds (kg/cm²) using a digital algometer applied bilaterally to the most painful areas of the lower extremities.
- Biomechanical and Postural Assessment: Static observational assessments are conducted to identify the presence of lower extremity mechanical deviations, specifically genu valgum and foot overpronation.
- Quality of Life and Physical Activity: Health-related quality of life is measured using the Nottingham Health Profile (NHP). The participants' physical activity levels and sedentary behaviors are quantified using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Statistical Analysis:
Data analysis will be performed using IBM SPSS Statistics. Group comparisons for continuous variables will utilize independent samples t-tests or Mann-Whitney U tests, depending on data normality. Categorical variables will be analyzed using Chi-Square or Fisher's Exact tests. Correlation analyses will be conducted using Pearson or Spearman tests, and logistic regression models may be applied to evaluate independent factors associated with hypermobility.
- Conditions
- Lipedema, Hypermobility, Joint
- Keywords
- Joint Hypermobility, Beighton Score, Lipedema, Connective Tissue Laxity
- Medical subject headings
- Lipedema, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lipedema Group | Women diagnosed with lipedema according to clinical criteria. | |
| Control Group | Healthy female volunteers matched for age and BMI, without lipedema diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beighton Score
The Beighton Scoring System is used to assess generalized joint hypermobility. Total scores range from a minimum of 0 to a maximum of 9. A higher score indicates a greater degree of joint hypermobility (a worse outcome). A score of 5 or higher is considered positive for generalized joint hypermobility.
Measured: Baseline (measured at the time of enrollment)
Secondary outcomes (6)
Pain Intensity
A self-reported visual analog scale to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). (Assessed in the Lipedema Group only)
Measured: Baseline
Algometric Assessment
Pressure pain threshold measured using a digital algometer (kg/cm²) on the lower extremities. Lower values indicate higher pain sensitivity. (Assessed in the Lipedema Group only)
Measured: Baseline
Subcutaneous Adipose Tissue Thickness
Measured bilaterally in millimeters (mm) using ultrasonography at 6-8 cm proximal to the medial malleolus. The average thickness is used for ultrasonographic staging of lipedema (Stage 1 to 4). (Assessed in the Lipedema Group only).
Measured: Baseline
Nottingham Health Profile (NHP)
The NHP is a questionnaire used to assess health-related quality of life, consisting of 38 questions across 6 domains (energy, pain, emotional reactions, sleep, social isolation, and physical mobility). Each domain is scored from 0 to 100, yielding a total profile score ranging from a minimum of 0 to a maximum of 600. Higher scores indicate worse health-related quality of life (a worse outcome). (Assessed in the Lipedema Group only).
Measured: Baseline
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
The IPAQ-SF is used to assess physical activity levels. Results are calculated as a continuous score in MET-minutes/week. The minimum possible score is 0 MET-minutes/week, with no theoretical maximum limit. Higher scores indicate higher levels of physical activity (a better outcome). (Assessed in the Lipedema Group only).
Measured: Baseline
Observational Postural Analysis
Presence of foot deformities (specifically pes planus / overpronation) and knee deformities (specifically genu valgum) will be evaluated observationally in a standing position. Findings will be recorded as "Present" or "Absent". (Assessed in the Lipedema Group only)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Aug 2025
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan ERDINC GUNDUZ, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808242
- Sponsor's protocol ID
- 2025/26-27
- Acronym
- LIP-HYP
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and maintain data confidentiality. The informed consent forms approved by the local Ethics Committee explicitly state that personal clinical data will be kept confidential and will not be shared with third-party researchers. Therefore, only aggregated data will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Hypermobility and Associated Factors in Patients With Lipedema: Turkish Population Data
- ClinicalTrials.gov ID
- NCT07808242
- Acronym / sponsor ID
- LIP-HYP / 2025/26-27
- Conditions
- Lipedema, Hypermobility, Joint
- Keywords
- Joint Hypermobility, Beighton Score, Lipedema, Connective Tissue Laxity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 8 Sep 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 observational study is to determine the prevalence of joint hypermobility in female patients with lipedema compared to healthy volunteers. Additionally, the study investigates how the presence of hypermobility in lipedema patients relates to the clinical and ultrasonographic stage of the disease, regional pain severity, pain sensitivity, postural status (such as genu valgum and foot overpronation), quality of life, and physical activity levels. The study includes 65 female patients clinically diagnosed with lipedema and 65 healthy female volunteers matched for age and body mass index.
Detailed description
Study Overview and Design This research is designed as a cross-sectional, case-control observational study to investigate the prevalence of joint hypermobility in female patients with lipedema. The study cohort is divided into two matched groups: female patients clinically diagnosed with lipedema and a control group of healthy female volunteers strictly matched for age and Body Mass Index (BMI).
Primary and Secondary Objectives The primary objective of this study is to evaluate and compare the prevalence of generalized joint hypermobility (GJH) between the lipedema group and the healthy control group using the validated Beighton Scoring System.
The secondary objective focuses exclusively on the lipedema cohort to analyze the potential biomechanical and clinical impacts of hypermobility. It aims to determine the relationship between hypermobility status and various clinical parameters, including regional pain severity, pressure pain thresholds, lower extremity postural deviations, subcutaneous tissue thickness, and overall health-related quality of life.
Clinical Evaluations and Outcome Measures:
- Lipedema Staging and Ultrasonography: Patients undergo clinical staging (Stages 1 to 3) and typing (Types I to V) based on the anatomical distribution of the pathological adipose tissue. Subcutaneous adipose tissue thickness is measured bilaterally using a 7-11 MHz linear ultrasound probe at 6-8 cm proximal to the medial malleolus.
- Joint Hypermobility: Assessed globally using the Beighton Score. A threshold score of 5 or higher out of 9 is utilized to indicate the presence of generalized joint hypermobility.
- Pain Assessment: Evaluated through two distinct methods. Subjective pain intensity is recorded using a Visual Analog Scale (VAS, 0-10) across six bilateral anatomical regions (entire leg, thigh, knee, calf, ankle, and foot sole). Objective pain sensitivity is measured via pressure pain thresholds (kg/cm²) using a digital algometer applied bilaterally to the most painful areas of the lower extremities.
- Biomechanical and Postural Assessment: Static observational assessments are conducted to identify the presence of lower extremity mechanical deviations, specifically genu valgum and foot overpronation.
- Quality of Life and Physical Activity: Health-related quality of life is measured using the Nottingham Health Profile (NHP). The participants' physical activity levels and sedentary behaviors are quantified using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Statistical Analysis:
Data analysis will be performed using IBM SPSS Statistics. Group comparisons for continuous variables will utilize independent samples t-tests or Mann-Whitney U tests, depending on data normality. Categorical variables will be analyzed using Chi-Square or Fisher's Exact tests. Correlation analyses will be conducted using Pearson or Spearman tests, and logistic regression models may be applied to evaluate independent factors associated with hypermobility.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipedema Group | – | –Women diagnosed with lipedema according to clinical criteria. |
| Control Group | – | –Healthy female volunteers matched for age and BMI, without lipedema diagnosis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lipedema Group: Female patients, aged between 18 and 65 years, who were clinically diagnosed with lipedema based on detailed physical examination and clinical assessments. The participants were evaluated and recruited at the Dokuz Eylul University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic. Control Group: Healthy female volunteers, aged between 18 and 65 years, who were strictly matched to the lipedema group in terms of age and Body Mass Index (BMI).
Key inclusion criteria (4 listed)
- For Lipedema Group:
- Aged between 18-65 years. Diagnosed with lipedema. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
- For Control Group:
- Aged between 18-65 years. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
Key exclusion criteria (9 listed)
- For Lipedema Group:
- Uncontrolled thyroid dysfunction. Chronic venous insufficiency and/or lymphedema (Stage 4 lipedema). Acute or chronic renal failure. Heart failure. Active cancer or ongoing cancer treatment. Presence of neurological disease. Presence of rheumatological disease. History of liposuction or major surgery for lipedema within the last 6 months. Visual or hearing impairment severe enough to affect study compliance. Illiteracy or cognitive impairment preventing the ability to give written informed consent.
- For Control Group:
- Previous diagnosis of lipedema, lymphedema, chronic venous insufficiency. History of rheumatologic, neurologic, endocrinologic, or cardiovascular diseases.
- Uncontrolled thyroid dysfunction. History of acute or chronic renal failure, heart failure, active cancer, or ongoing cancer treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beighton Score
Time frame: Baseline (measured at the time of enrollment)
The Beighton Scoring System is used to assess generalized joint hypermobility. Total scores range from a minimum of 0 to a maximum of 9. A higher score indicates a greater degree of joint hypermobility (a worse outcome). A score of 5 or higher is considered positive for generalized joint hypermobility.
6 secondary outcomes
Pain Intensity
Time frame: Baseline
Algometric Assessment
Time frame: Baseline
Subcutaneous Adipose Tissue Thickness
Time frame: Baseline
Nottingham Health Profile (NHP)
Time frame: Baseline
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: Baseline
Observational Postural Analysis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and maintain data confidentiality. The informed consent forms approved by the local Ethics Committee explicitly state that personal clinical data will be kept confidential and will not be shared with third-party researchers. Therefore, only aggregated data will be reported in publications.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypermobility, Joint, 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 4 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: finished, as of the sponsor's last update on 8 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?
Beighton Score (time frame: Baseline (measured at the time of enrollment)). 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 8 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.