NCT05945030

Brief Summary

Patients with diabetes with clinical feature of Xanthelasma will show increased Atherosclerosis. Objectives: Primary

  1. 1.To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler.
  2. 2.To correlate xanthelasma to liver fat and fibrosis.
  3. 3.Clinical History and Examination:
  4. 4.Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
  5. 5.Fasting blood Glucose
  6. 6.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)
  7. 7.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.
  8. 8.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).
  9. 9.Assessment of sub-clinical atherosclerosis: Pulse wave velocity and carotid Doppler will be done
  10. 10.Pulse wave velocity: Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity.
  11. 11.Carotid Doppler: (based on kinetic method)
  12. 12.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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 3, 2023

Last Update Submit

July 11, 2023

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

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

    Patient with T2DM and Xanthelasma have a high risk of atherosclerosis.

    12 month

Study Arms (2)

With Xanthelasma

T2DM with Xanthelasma

Other: Clinical Examination

Without Xanthelasma

T2DM without Xanthelasma

Interventions

Clinical ExaminationOTHER

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

With Xanthelasma

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis CDOC Hospital

Delhi, 110048, India

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Anoop Misra, MD

    Fortis CDOC Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anoop Misra, MD

CONTACT

01149101222anoopmisra@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 14, 2023

Study Start

July 1, 2023

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)