NCT07240298

Brief Summary

Women aged 18-75 years with a clinical diagnosis of lipedema and an obese control group will be included in the study. Sociodemographic and clinical data (age, height, weight, medications, etc.) of the participants will be recorded. For laboratory evaluation, fasting blood test results obtained within the last three months (including fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides) will be used. Based on these parameters, metabolic and atherogenic risk indicators such as the Triglyceride-Glucose Index (TyG), TyG-BMI, Atherogenic Index of Plasma (AIP), Atherogenic Coefficient (AC), Castelli Risk Index I (CRI-I), and Castelli Risk Index II (CRI-II) will be calculated. No additional biochemical tests will be collected from participants; analyses will be performed using existing laboratory results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Triglyceride-Glucose Index (TyG):

    The TyG index will be calculated as ln \[fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2\]. It serves as a surrogate marker for insulin resistance. Higher values indicate greater metabolic risk.

    Baseline

Secondary Outcomes (5)

  • TyG-BMI

    Baseline

  • Atherogenic Index of Plasma (AIP):

    Baseline

  • Atherogenic Coefficient (AC):

    Baseline

  • Castelli Risk Index I (CRI-I):

    Baseline

  • Castelli Risk Index II (CRI-II):

    Baseline

Study Arms (2)

Lipedema group

Obese patients with lipedema

Other: No intervention

Control group

Obese patients without lipedema

Other: No intervention

Interventions

No intervention

Control groupLipedema group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

obese patients with and without lipedema

You may qualify if:

  • Clinically diagnosed with lipedema
  • Obese control group with BMI ≥30 kg/m² who do not meet lipedema criteria
  • Aged between 18 and 75 years
  • Availability of fasting lipid profile and fasting glucose tests within the past 3 months
  • Provided voluntary informed consent

You may not qualify if:

  • Use of medications that routinely affect lipid or glucose metabolism: statins, fibrates, niacin, ezetimibe, high-dose omega-3 supplements, GLP-1 receptor agonists, SGLT2 inhibitors, or systemic corticosteroids (regular use within the past 3 months)
  • Presence of rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or active malignancy
  • Neurological disorders (e.g., polyneuropathy, multiple sclerosis, history of stroke)
  • Pregnancy or lactation
  • History of lower extremity surgery or major trauma within the past 6 months
  • Received injection therapy or physical therapy for the lower extremities within the past 6 months
  • Active infection or dermatological disease affecting the lower extremities
  • History of significant venous insufficiency or acute deep vein thrombosis (DVT)
  • Alcohol or substance abuse
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

October 10, 2025

Primary Completion

November 10, 2025

Study Completion

November 10, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations