UnknownNot Applicable

Correlation of Xanthelasma With Atherosclerosis, Hepatic Fat and Fibrosis

India150 participantsStarted 2023-07-01

Plain-language summary

Patients with diabetes with clinical feature of Xanthelasma will show increased Atherosclerosis. Objectives: Primary 1. To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler. Secondary 2. To correlate xanthelasma to liver fat and fibrosis. Methodology: T2DM patient will be recruited from endocrine OPD 1. Clinical History and Examination: a. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Xanthelasma. 2. Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits 1. Fasting blood Glucose 2. Haemoglobin A1C: The estimation of average blood sugar level over a period of two to three months will be analysed with the patient's blood sample for haemoglobin A1C based on turbidimetric inhibition immunoassay method (using COBAS 6000 analyser) 3. Lipid Profile: Fasting samples shall be analysed for lipid profile. Levels of total cholesterol (TC), serum triglyceride (TG) and high-density lipoprotein cholesterol (HDL-c) will be estimated using commercial kits (Randox Laboratory, USA). Value of low-density lipoprotein cholesterol (LDL-c) will be calculated according to Friedewald's equation. 4. Liver Function Tests: Fasting samples shall be analysed for liver function test. Levels of alkaline phosphate, Aspartate aminotransferase, Alanine aminotransferase and Gamma-glutamyl transferase will be estimated by using commercial kits (based on kinetic method). 3. Assessment of sub-clinical atherosclerosis: Pulse wave velocity and carotid Doppler will be done 1. Pulse wave velocity: Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity. 2. Carotid Doppler: (based on kinetic method) 3. FibroScan Estimation: It is a medical diagnostic tool. Liver stiffness (LSM in kPa) and controlled attenuation parameter (CAP in dB/m) measurements will be done by transient elastography (FibroScan® 430 Touch, Echosens, FR) in order to quantify severity of liver fibrosis (LSM 7-10 kPa for F1, 10.1-13 for F2 and \>13kPa for F≥3

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

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Inclusion criteria

. Patients with T2DM
. Age 25 to 60 years
. BMI \>25 kg/m² to \>40 kg/m²
. Gender- Both (Male \& Female)
. Mild, moderate and severe Xanthelasma (Photograph)

Exclusion criteria

. Alcoholic abuse or other causes of liver dysfunction.
. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine correlation of Xanthelasma with Pulse wave velocity, Carotid Doppler scores and Fibrosis

Timeframe: 12 month

Trial details

NCT IDNCT05945030

SponsorDiabetes Foundation, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-30

Contact for this trial

Anoop Misra, MD

01149101222 anoopmisra@gmail.com

View on ClinicalTrials.gov More Type2diabetes trials