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NCT Number: NCT07204782

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university

Asyut, Egypt

Location contact

Aya AM Morsy, bachlor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The prevalence of elevated 10-year cardiovascular risk scores among patients with type 2 diabetes mellitus.

    Time frame: 1 YEAR

    Measurement tool: WHO cardiovascular risk chart

    Unit of measure: % of patients with ≥10% predicted 10-year cardiovascular risk

Secondary outcomes

  1. The correlation between cardiovascular risk scores and non-invasive visceral adiposity indices (such as LAP and VAI).

    Time frame: 1 YEAR

    Tools: WHO cardiovascular risk chart, LAP & VAI indices

    Unit: Correlation coefficient

Other outcomes

  1. The relationship between cardiovascular risk and clinical/lifestyle factors (e.g., duration of diabetes, BMI, physical activity, smoking, blood pressure, lipid profile).

    Time frame: 1 YEAR

    Tools: WHO cardiovascular risk chart, clinical records, questionnaires, lab tests

    Unit: Regression / correlation coefficients

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Elevated Cardiovascular Risk Scores With Diabetes Mellitus Type 2 and Their Association With Non-Invasive Visceral Adiposity Indices

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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