LipedemaNCT07240298
Comparison of Triglyceride-Glucose Index and Atherogenic Indices Between Patients With Lipedema and Obese Controls
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 10 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: obese patients with and without lipedema
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: 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.
- Conditions
- Lipedema
- Being tested
- No intervention
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Lipedema group | Obese patients with lipedema Receives: Other: No intervention | |
| Control group | Obese patients without lipedema Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
TyG-BMI
Calculated by multiplying the TyG index by body mass index (BMI). Higher values indicate increased insulin resistance and metabolic risk.
Measured: Baseline
Atherogenic Index of Plasma (AIP):
Calculated as log (triglycerides / HDL-cholesterol). Higher AIP values reflect greater atherogenic risk.
Measured: Baseline
Atherogenic Coefficient (AC):
Calculated as (total cholesterol - HDL-cholesterol) / HDL-cholesterol. Higher scores indicate higher atherogenic potential.
Measured: Baseline
Castelli Risk Index I (CRI-I):
Calculated as total cholesterol / HDL-cholesterol. Higher values indicate increased cardiovascular risk.
Measured: Baseline
Castelli Risk Index II (CRI-II):
Calculated as LDL-cholesterol / HDL-cholesterol. Higher scores represent greater atherogenic risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Oct 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240298
- Sponsor's protocol ID
- istftreah1
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Triglyceride-Glucose Index and Atherogenic Indices Between Patients With Lipedema and Obese Controls: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07240298
- Acronym / sponsor ID
- istftreah1
- Conditions
- Lipedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipedema group | – | Other: No interventionObese patients with lipedema |
| Control group | – | Other: No interventionObese patients without lipedema |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients with and without lipedema
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Control group, Lipedema group |
Primary outcome
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.
5 secondary outcomes
TyG-BMI
Time frame: Baseline
Atherogenic Index of Plasma (AIP):
Time frame: Baseline
Atherogenic Coefficient (AC):
Time frame: Baseline
Castelli Risk Index I (CRI-I):
Time frame: Baseline
Castelli Risk Index II (CRI-II):
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride-Glucose Index (TyG): (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.