Metabolic markers linked to pain and central sensitization in women with lipedema
THE IMPACT OF METABOLIC STATUS ON PAIN AND CENTRAL SENSITIZATION IN WOMEN WITH LIPEDEMA: A CROSS-SECTIONAL OBSERVATIONAL STUDY
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 |
|---|---|
| Enrollment | 59 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Pendik) |
| Trial ID | NCT07468097 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul, Pendik
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.