MedTrace Logo

Correlation of Xanthelasma With Atherosclerosis, Hepatic Fat and Fibrosis

NCT05945030 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-07-14

No results posted yet for this study

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

Conditions

  • Type2diabetes

Interventions

OTHER

Clinical Examination

T2DM patient visiting Fortis CDOC will undergo clinical examination to determine the grade of Xanthelasma.

Sponsors & Collaborators

  • National Diabetes Obesity and Cholesterol Foundation

    collaborator OTHER

  • Diabetes Foundation, India

    lead OTHER

Principal Investigators

  • Anoop Misra, MD · Fortis CDOC Hospital

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-07-30
Completion
2024-08-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945030 on ClinicalTrials.gov