Metabolic markers linked to pain and central sensitization in women with lipedema
Official title: THE IMPACT OF METABOLIC STATUS ON PAIN AND CENTRAL SENSITIZATION IN WOMEN WITH LIPEDEMA: A CROSS-SECTIONAL OBSERVATIONAL STUDY
Run by Marmara University · NCT07468097 · Data updated 2026-11-12
This study will test whether metabolic measures like insulin resistance (HOMA-IR), triglyceride/HDL ratio, and HbA1c are linked to central sensitization and pain in women with lipedema.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 59 (estimated) |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Pendik) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07468097 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with a diagnosis of lipedema, chronic pain for at least three months, capacity to consent and complete assessments, and not taking antidiabetic or lipid-lowering medications are ideal candidates.
✕Probably not a fit
People who are pregnant or breastfeeding, have diagnosed diabetes, active thyroid or other significant endocrine disorders, active infection, malignancy, severe systemic disease, major neurological/psychiatric disorders, or who are on antidiabetic or lipid-lowering therapy are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This cross-sectional observational study will enroll adult women with diagnosed lipedema and chronic pain to collect metabolic markers (HOMA-IR, TG/HDL, HbA1c, fasting glucose/insulin), anthropometric measures (waist/hip circumference, BMI), and standardized pain and central sensitization assessments. Pain characterization will include intensity, pain phenotype, functional status, and validated central sensitization questionnaires, with possible quantitative sensory testing. Participants with diabetes, active endocrine or severe systemic disease, significant neurological or psychiatric disorders, or on antidiabetic or lipid-lowering medications are excluded to reduce confounding. Data analysis will examine associations between metabolic dysfunction and measures of central pain processing and clinical pain outcomes.
Why it matters
Potential benefit: If links are found, the findings could point to metabolic targets or lifestyle strategies to help reduce pain or central sensitization in women with lipedema.
How similar studies have gone: Metabolic dysfunction has been linked to chronic pain in other conditions, but applying these observations to lipedema is relatively novel and supported by limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where it's running
-
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Pendik, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Fatma B Akdağ
- Email: fatma.betul820@gmail.com
- Phone: +90 537 452 96 60
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.