- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240298
Comparison of Triglyceride-Glucose Index and Atherogenic Indices Between Patients With Lipedema and Obese Controls
November 16, 2025 updated by: Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Comparison of Triglyceride-Glucose Index and Atherogenic Indices Between Patients With Lipedema and Obese Controls: A Cross-Sectional Study
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
obese patients with and without lipedema
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lipedema group
Obese patients with lipedema
|
No intervention
|
|
Control group
Obese patients without lipedema
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Triglyceride-Glucose Index (TyG):
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TyG-BMI
Time Frame: Baseline
|
Calculated by multiplying the TyG index by body mass index (BMI).
Higher values indicate increased insulin resistance and metabolic risk.
|
Baseline
|
|
Atherogenic Index of Plasma (AIP):
Time Frame: Baseline
|
Calculated as log (triglycerides / HDL-cholesterol).
Higher AIP values reflect greater atherogenic risk.
|
Baseline
|
|
Atherogenic Coefficient (AC):
Time Frame: Baseline
|
Calculated as (total cholesterol - HDL-cholesterol) / HDL-cholesterol.
Higher scores indicate higher atherogenic potential.
|
Baseline
|
|
Castelli Risk Index I (CRI-I):
Time Frame: Baseline
|
Calculated as total cholesterol / HDL-cholesterol.
Higher values indicate increased cardiovascular risk.
|
Baseline
|
|
Castelli Risk Index II (CRI-II):
Time Frame: Baseline
|
Calculated as LDL-cholesterol / HDL-cholesterol.
Higher scores represent greater atherogenic risk.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2025
Primary Completion (Actual)
November 10, 2025
Study Completion (Actual)
November 10, 2025
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- istftreah1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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