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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

59 Participants
are grouped into 1 trial group
Group A: Female patients diagnosed with lipedema

Trial outcomes

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.

Time frame
At baseline

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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

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