Central SensitizationNCT07468097
The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational Study
An observational study of Central Sensitization and Lipedema, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Central Sensitization, Lipedema, Pain
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 1 Mar 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older with a diagnosis of lipedema who have undergone laboratory testing in which metabolic markers were evaluated within the past three months.
Who may be able to join
- Being female and aged 18 years or older
- Having chronic pain persisting for at least 3 months
- Having sufficient cognitive ability to understand and respond to the assessment scales used in the study
- Voluntarily agreeing to participate in the study and providing written informed consent
Who cannot join
- Presence of a history of malignancy, active infection, inflammatory rheumatic disease, or severe systemic disease
- History of known neurological disorders (e.g., stroke, multiple sclerosis, epilepsy)
- Diagnosis of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Pregnancy or breastfeeding
- Presence of cognitive impairment or communication difficulties that could affect the study results
- Diagnosed diabetes mellitus
Show all 13Show fewer
- Active thyroid disease (uncontrolled hypothyroidism or hyperthyroidism)
- Cushing's syndrome or other significant endocrine disorders
- Use of antidiabetic medications
- Use of lipid-lowering therapy (e.g., statins, fibrates)
- Systemic glucocorticoid use within the past 3 months
- Use of medications that may significantly affect central pain mechanisms (e.g., high-dose opioids, antipsychotic drugs)
- History of major surgery or invasive treatment for pain within the past 3 months
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
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Pendik, 34890
Secretary General Secretary, +90 2166254545, fatma.betul820@gmail.com
About this study
Official title: THE IMPACT OF METABOLIC STATUS ON PAIN AND CENTRAL SENSITIZATION IN WOMEN WITH LIPEDEMA: A CROSS-SECTIONAL OBSERVATIONAL STUDY
The aim of this study is to evaluate the effect of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
Read the detailed description
Lipedema is a chronic disorder observed in women, characterized by symmetrical accumulation of adipose tissue in the lower extremities, easy bruising, and marked tenderness or pain. In lipedema, pain is often spontaneous, increases with pressure, and does not always correlate with the amount of adipose tissue. This suggests that lipedema-related pain cannot be explained solely by peripheral mechanical factors.
Previous studies in patients with lipedema have demonstrated reduced pressure pain thresholds, bilateral and symmetrical hyperalgesia, and increased pain sensitivity extending beyond the areas of local adipose tissue involvement. These findings suggest that alterations in central pain processing mechanisms may occur in lipedema and that central sensitization may play a role. However, systematic studies specifically evaluating central sensitization in lipedema remain limited.
Although lipedema has long been considered a "metabolically protected" condition, recent studies have reported that insulin resistance, dyslipidemia, and components of metabolic syndrome are more frequently observed, particularly in lipedema cases accompanied by obesity. HOMA-IR, which is used to evaluate insulin resistance; the triglyceride/HDL ratio (TG/HDL), a marker of atherogenic dyslipidemia; and HbA1c, reflecting long-term glycemic load, are closely associated with chronic inflammation and metabolic dysfunction.
In the chronic pain literature, metabolic dysfunction has been shown to play an important role in the development of central sensitization and nociplastic pain, with obesity, insulin resistance, and dyslipidemia being associated with central pain amplification. However, to the best of our knowledge, no studies in lipedema have simultaneously evaluated the relationship between metabolic parameters, pain phenotype, and central sensitization.
The aim of this study is to evaluate the effects of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
- Conditions
- Central Sensitization, Lipedema, Pain, HOMA-IR
- Keywords
- Triglyceride, HOMA-IR, Pain, Fasting Blood Glucose, Fasting Insulin, Lipedema
- Medical subject headings
- Lipedema, Pain
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 |
|---|---|---|
| Female patients diagnosed with lipedema | Patients aged 18 years and older who are followed with a diagnosis of lipedema and who have undergone laboratory testing in which metabolic markers were evaluated within the last three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory (CSI)
The Central Sensitization Inventory is a self-report screening tool developed to assess the presence and severity of symptoms associated with central sensitization. The inventory evaluates symptoms reflecting sensitization in central nervous system pain-processing mechanisms, including widespread pain, fatigue, sleep disturbances, and cognitive complaints. The CSI consists of 25 items, each scored on a scale from 0 to 4, with a total score ranging from 0 to 100. A total score of 40 or higher is considered to be associated with a high likelihood of central sensitization.
Measured: At baseline
Secondary outcomes (7)
Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is used to measure and monitor pain intensity. A score of "0" represents no pain, while "10" indicates the worst pain imaginable. Patients are asked to rate their pain on a scale from 0 to 10. Due to its simplicity and ease of understanding, this scale is frequently used in clinical research.
Measured: At baseline
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale is a self-report measure used to evaluate the impact of fatigue on daily life and functional activities. The scale consists of 9 items, each scored on a scale from 1 to 7. Higher average scores indicate greater fatigue severity.
Measured: At baseline
Neuropathic Pain Diagnostic Questionnaire (DN4)
The DN4 questionnaire was developed to assess the presence of neuropathic pain. It consists of 10 items derived from symptom-based questions and clinical examination findings. The total score ranges from 0 to 10, and a score of 4 or higher is considered indicative of neuropathic pain.
Measured: At baseline
Short Form-12 (SF-12)
The Short Form-12 is a questionnaire used to assess general health status and health-related quality of life. It consists of 12 items. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: At baseline
Jenkins Sleep Scale (JSS)
The Jenkins Sleep Scale is a self-report measure consisting of four items that evaluates the frequency of sleep problems experienced over the past month. Higher scores indicate a greater frequency of sleep disturbance symptoms, such as difficulty falling asleep, nocturnal awakenings, and early morning awakening.
Measured: At baseline
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale is a self-report measure consisting of 20 items that evaluates lower extremity functional status during activities of daily living. Lower total scores indicate greater functional limitation, whereas higher scores reflect better lower extremity function.
Measured: At baseline
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure consisting of seven items that assess the time spent walking, performing moderate-intensity and vigorous-intensity activities, and sitting. The total score is calculated by considering the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous-intensity activity. Energy expenditure for these activities is expressed in MET-minutes. Standard MET values have been established for each activity: sitting 1.5 MET, walking 3.3 MET, moderate-intensity physical activity 4 MET, and vigorous-intensity physical activity 8 MET. Using these values, daily and weekly physical activity levels can be calculated.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitizationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468097
- Sponsor's protocol ID
- 09.2026.26-0134
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF METABOLIC STATUS ON PAIN AND CENTRAL SENSITIZATION IN WOMEN WITH LIPEDEMA: A CROSS-SECTIONAL OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT07468097
- Acronym / sponsor ID
- 09.2026.26-0134
- Conditions
- Central Sensitization, Lipedema, Pain, HOMA-IR
- Keywords
- Triglyceride, HOMA-IR, Pain, Fasting Blood Glucose, Fasting Insulin, Lipedema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Mar 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 evaluate the effect of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
Detailed description
Lipedema is a chronic disorder observed in women, characterized by symmetrical accumulation of adipose tissue in the lower extremities, easy bruising, and marked tenderness or pain. In lipedema, pain is often spontaneous, increases with pressure, and does not always correlate with the amount of adipose tissue. This suggests that lipedema-related pain cannot be explained solely by peripheral mechanical factors.
Previous studies in patients with lipedema have demonstrated reduced pressure pain thresholds, bilateral and symmetrical hyperalgesia, and increased pain sensitivity extending beyond the areas of local adipose tissue involvement. These findings suggest that alterations in central pain processing mechanisms may occur in lipedema and that central sensitization may play a role. However, systematic studies specifically evaluating central sensitization in lipedema remain limited.
Although lipedema has long been considered a "metabolically protected" condition, recent studies have reported that insulin resistance, dyslipidemia, and components of metabolic syndrome are more frequently observed, particularly in lipedema cases accompanied by obesity. HOMA-IR, which is used to evaluate insulin resistance; the triglyceride/HDL ratio (TG/HDL), a marker of atherogenic dyslipidemia; and HbA1c, reflecting long-term glycemic load, are closely associated with chronic inflammation and metabolic dysfunction.
In the chronic pain literature, metabolic dysfunction has been shown to play an important role in the development of central sensitization and nociplastic pain, with obesity, insulin resistance, and dyslipidemia being associated with central pain amplification. However, to the best of our knowledge, no studies in lipedema have simultaneously evaluated the relationship between metabolic parameters, pain phenotype, and central sensitization.
The aim of this study is to evaluate the effects of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients diagnosed with lipedema | – | –Patients aged 18 years and older who are followed with a diagnosis of lipedema and who have undergone laboratory testing in which metabolic markers were evaluated within the last three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older with a diagnosis of lipedema who have undergone laboratory testing in which metabolic markers were evaluated within the past three months.
Key inclusion criteria (4 listed)
- Being female and aged 18 years or older
- Having chronic pain persisting for at least 3 months
- Having sufficient cognitive ability to understand and respond to the assessment scales used in the study
- Voluntarily agreeing to participate in the study and providing written informed consent
Key exclusion criteria (13 listed)
- Presence of a history of malignancy, active infection, inflammatory rheumatic disease, or severe systemic disease
- History of known neurological disorders (e.g., stroke, multiple sclerosis, epilepsy)
- Diagnosis of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Pregnancy or breastfeeding
- Presence of cognitive impairment or communication difficulties that could affect the study results
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
Central Sensitization Inventory (CSI)
Time frame: At baseline
The Central Sensitization Inventory is a self-report screening tool developed to assess the presence and severity of symptoms associated with central sensitization. The inventory evaluates symptoms reflecting sensitization in central nervous system pain-processing mechanisms, including widespread pain, fatigue, sleep disturbances, and cognitive complaints. The CSI consists of 25 items, each scored on a scale from 0 to 4, with a total score ranging from 0 to 100. A total score of 40 or higher is considered to be associated with a high likelihood of central sensitization.
7 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: At baseline
Fatigue Severity Scale (FSS)
Time frame: At baseline
Neuropathic Pain Diagnostic Questionnaire (DN4)
Time frame: At baseline
Short Form-12 (SF-12)
Time frame: At baseline
Jenkins Sleep Scale (JSS)
Time frame: At baseline
Lower Extremity Functional Scale (LEFS)
Time frame: At baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: At 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 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Central Sensitization and Lipedema, run by Marmara 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 13 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 12 Mar 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 Fatma B Akdağ (+90 537 452 96 60, fatma.betul820@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: At baseline). 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 12 Mar 2026.