The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational Study

NCT07468097 | Recruiting

• 1 other identifier: 09.2026.26-0134
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline

Secondary Outcomes (7)

• Numeric Rating Scale (NRS)

  At baseline

• Fatigue Severity Scale (FSS)

  At baseline

• Neuropathic Pain Diagnostic Questionnaire (DN4)

  At baseline

• Short Form-12 (SF-12)

  At baseline

• Jenkins Sleep Scale (JSS)

  At baseline

Other Outcomes (3)

• HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

  At baseline

• Triglyceride/HDL Cholesterol (TG/HDL) Ratio

  At baseline

• Waist-to-Hip Ratio

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, Pendik, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lipedema; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma B Akdağ

CONTACT

+90 537 452 96 60; fatma.betul820@gmail.com

Yeliz Özdemir

CONTACT

+90 536 846 94 97; yelizbahar1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)