Comparison of Triglyceride-Glucose Index and Atherogenic... | NCT07240298

Studies
Comparison of Triglyceride-Glucose Index and Atherogenic Indices Between Patients With Lipedema and Obese Controls

NCT07240298

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Lipedema

Interventions

No intervention

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2025Actual

Primary Completion Date

Nov 10, 2025Actual

Completion Date

Nov 10, 2025Actual

First Submitted Date

Nov 16, 2025

First Submission Date that Met QC Criteria

Nov 16, 2025

First Posted Date

Nov 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2025

Last Update Posted Date

Nov 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatma Nur Kesiktaş, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitalPrincipal Investigator

Lead Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lipedema group		Obese patients with lipedema	Other: No intervention
Control group		Obese patients without lipedema	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Control group Lipedema group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
TyG-BMI	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):

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

obese patients with and without lipedema

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Physical Medicine Rehabilitation Training and Research Hospital		Istanbul			Turkey (Türkiye)

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases