Link between Xanthelasma and Atherosclerosis in Diabetes
Association of Xanthelasma With Sub Clinical Atherosclerosis and Hepatic Fat: A Case Control Prospective Study
This study is trying to see if the yellow skin plaques called xanthelasma are linked to heart artery problems in people with Type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Diabetes Foundation, India Academic / other |
| Locations | 1 site (Delhi) |
| Trial ID | NCT05945030 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the correlation between xanthelasma, a skin condition characterized by yellow plaques, and the severity of atherosclerosis in patients with Type 2 diabetes mellitus (T2DM). The study will recruit T2DM patients from an endocrine outpatient department and assess their clinical history, physical examination, and biochemical tests, including fasting blood glucose and lipid profiles. The primary objective is to correlate the severity of xanthelasma with pulse wave velocity and carotid atherosclerosis, while secondary objectives include examining its relationship with liver fat and fibrosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 25 to 60 years with Type 2 diabetes and varying severity of xanthelasma.
Not a fit: Patients with severe end organ damage, chronic diseases, or those with liver dysfunction due to alcohol abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the early identification of cardiovascular risks in diabetic patients through the assessment of xanthelasma.
How similar studies have performed: While the correlation between xanthelasma and cardiovascular conditions has been noted in previous studies, this specific approach focusing on T2DM patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with T2DM 2. Age 25 to 60 years 3. BMI \>25 kg/m² to \>40 kg/m² 4. Gender- Both (Male \& Female) 5. Mild, moderate and severe Xanthelasma (Photograph) Exclusion Criteria: 1. Alcoholic abuse or other causes of liver dysfunction. 2. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Where this trial is running
Delhi
- Fortis CDOC Hospital — Delhi, India (Recruiting)
Study contacts
- Principal investigator: Anoop Misra, MD — Fortis CDOC Hospital
- Study coordinator: Anoop Misra, MD
- Email: anoopmisra@gmail.com
- Phone: 01149101222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.