An observational study in Central Sensitization, Lipedema and Pain, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Marmara University · Observational
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.
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 59 is below the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: At baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline
HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
HOMA-IR is an index widely used to assess insulin resistance and is calculated using fasting glucose and fasting insulin levels. In this study, HOMA-IR will be calculated using the following formula: HOMA-IR = \[Fasting insulin (µIU/mL) × Fasting glucose (mg/dL)\] / 405. Although there is no universally accepted single cut-off value for HOMA-IR, studies conducted in adult populations commonly interpret HOMA-IR values as follows: \<1.0 indicates normal insulin sensitivity, 1.0-1.9 borderline insulin resistance, and ≥2.0 suggestive of insulin resistance; particularly HOMA-IR ≥2.5 is frequently used as a threshold indicating insulin resistance. In this study, HOMA-IR will be evaluated both as a continuous variable and categorized according to these commonly used reference values in the literature.
Time frame: At baseline
Triglyceride/HDL Cholesterol (TG/HDL) Ratio
The TG/HDL ratio is a metabolic indicator obtained by dividing the serum triglyceride level by the high-density lipoprotein cholesterol (HDL) level and is associated with atherogenic dyslipidemia and insulin resistance. In this study, the TG/HDL ratio will be calculated using the formula TG (mg/dL) / HDL (mg/dL). Although there is no universally accepted cut-off value for the TG/HDL ratio, studies conducted in adult populations commonly classify values as follows: \<2.0 normal, 2.0-3.0 borderline, and ≥3.0 indicative of increased metabolic risk; particularly TG/HDL ≥3.5 is frequently considered associated with insulin resistance and increased cardiometabolic risk. In this study, the TG/HDL ratio will be categorized according to these commonly used reference values in the literature.
Time frame: At baseline
Waist-to-Hip Ratio
The waist-to-hip ratio is calculated by dividing waist circumference by hip circumference and is used to assess abdominal fat distribution. In women, a value of ≥0.85 is considered indicative of central obesity and increased cardiometabolic risk.
Time frame: At baseline
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.