Cardiovascular Disease CVD Constitutes a Significant Health Challenge for Individuals With Type 2 Diabetes Mellitus T2DM, Affecting Approximately 32% of This Population and Contributing Significantly to Global Mortality.Visceral Adipose Tissue VAT Accumulation Has Been Recognize

Not yet recruiting

• Conditions: Diabete Mellitus

• Registration Number: NCT07204782
• Lead Sponsor: Assiut University

Brief Summary

calculate cardiovascular risk scores in type 2 DM patients, then estimate its association with new visceral adipose tissue indices

Detailed Description

Cardiovascular disease (CVD) constitutes a significant health challenge for individuals with type 2 diabetes mellitus (T2DM), affecting approximately 32% of this population and contributing significantly to global mortality.Visceral adipose tissue (VAT) accumulation has been recognized as a major contributor to adverse cardiac remodelling. Unlike subcutaneous adipose tissue (SAT), VAT is metabolically active, promoting a pro-inflammatory, lipotoxic, and insulin-resistant environment that accelerates myocardial fibrosis, hypertrophy, and diastolic dysfunction. Despite its clinical significance, VAT is challenging to measure in routine practice. Advanced imaging modalities such as magnetic resonance imaging provide direct VAT assessment but it's costly, time-consuming, and impractical for large-scale screening. In contrast, traditional anthropometric measures like body mass index (BMI), waist circumference (WC), and waist-to-hip ratio (WHR) do not distinguish VAT from SAT and fail to capture the true cardiometabolic burden of visceral fat .To address these limitations, researchers have focused on developing non-invasive visceral obesity indices that combine anthropometric and laboratory-based parameters. These indices are particularly relevant for T2DM patients, as insulin resistance often occurs when fat accumulates in intra-abdominal depots and is associated with a constellation of CVD risk factors, in what is known as the metabolic syndrome.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-12-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Adult patients ≥40 years old attending the out patients clinics
• Patients diagnosed with type 2 diabetes mellitus

Exclusion Criteria

• Patient with a history of cardiovascular events

• Patient with type 1 diabetes or gestational diabetes.

• Pregnant women.

• Hypothyroidism,

• Cushing disease

• polycystic ovarian syndrome.

• Congestive heart failure

• chronic liver disease

  .- chronic kidney disease,

• cancer

• Current use of steroids, birth control pills, antipsychotics, antidepressants, epilepsy drugs.

• Patients with physical deformities or conditions affecting anthropometric measurements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of elevated 10-year cardiovascular risk scores among patients with type 2 diabetes mellitus.	1 YEAR	Measurement tool: WHO cardiovascular risk chart; Unit of measure: % of patients with ≥10% predicted 10-year cardiovascular risk

Secondary Outcome Measures

Name	Time	Method
The correlation between cardiovascular risk scores and non-invasive visceral adiposity indices (such as LAP and VAI).	1 YEAR	Tools: WHO cardiovascular risk chart, LAP \& VAI indices; Unit: Correlation coefficient

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Asyut, Egypt