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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey (Türkiye)
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lipedema group
Obese patients with lipedema
Other: No intervention
No intervention
Control group
Obese patients without lipedema
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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