NCT07204782

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress30%
Dec 2025Jul 2027

First Submitted

Initial submission to the registry

September 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 20, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

cardiovascular risk scoresvisceral adiposity indicesdiabetes mellitusVATLAP

Outcome Measures

Primary Outcomes (1)

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

    Measurement tool: WHO cardiovascular risk chart Unit of measure: % of patients with ≥10% predicted 10-year cardiovascular risk

    1 YEAR

Secondary Outcomes (1)

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

    1 YEAR

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).

    1 YEAR

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic patients attending Assiut university

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (3)

  • Tawfik MY, Mohamed SF, Elotla SF. Association of novel visceral obesity indices with 10-year risk of major cardiovascular events in patients with type 2 diabetes mellitus. J Egypt Public Health Assoc. 2025 May 30;100(1):12. doi: 10.1186/s42506-025-00188-w.

    PMID: 40445502BACKGROUND
  • Wang L, Liu S, Ke J, Cao B, Wang D, Zhao Q, Gong H, Fang Y, Zheng Z, Yu C, Wu N, Ma Y, Yu K, Yang L, Zhao D. Association between metabolic visceral fat score and left ventricular hypertrophy in individuals with type 2 diabetes. Diabetol Metab Syndr. 2025 Mar 6;17(1):81. doi: 10.1186/s13098-025-01648-1.

    PMID: 40050939BACKGROUND
  • Einarson TR, Acs A, Ludwig C, Panton UH. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017. Cardiovasc Diabetol. 2018 Jun 8;17(1):83. doi: 10.1186/s12933-018-0728-6.

    PMID: 29884191BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 20, 2025

First Posted

October 2, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations