Diabete MellitusNCT07204782
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
An observational study of Diabete Mellitus, run by Assiut University at 1 site in Egypt.
Trial summary
calculate cardiovascular risk scores in type 2 DM patients, then estimate its association with new visceral adipose tissue indices Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabete Mellitus
- How many people
- 238 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients attending Assiut university
Who may be able to join
- Adult patients ≥40 years old attending the out patients clinics
- Patients diagnosed with type 2 diabetes mellitus
Who cannot join
- Patient with a history of cardiovascular events
- Patient with type 1 diabetes or gestational diabetes.
- Pregnant women.
- Hypothyroidism,
- Cushing disease
- polycystic ovarian syndrome.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Elevated Cardiovascular Risk Scores With Diabetes Mellitus Type 2 and Their Association With Non-Invasive Visceral Adiposity Indices
calculate cardiovascular risk scores in type 2 DM patients, then estimate its association with new visceral adipose tissue indices
Read the 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.
- Conditions
- Diabete Mellitus
- Keywords
- cardiovascular risk scores, visceral adiposity indices, diabetes mellitus, VAT, LAP
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 YEAR
Secondary outcomes (1)
The correlation between cardiovascular risk scores and non-invasive visceral adiposity indices (such as LAP and VAI).
Tools: WHO cardiovascular risk chart, LAP \& VAI indices
Unit: Correlation coefficient
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Mohamed Morsy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204782
- Sponsor's protocol ID
- Visceral adiposity indices
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40445502Wang 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.
PubMed 40050939Einarson 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.
PubMed 29884191
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Cardiovascular Risk Scores With Diabetes Mellitus Type 2 and Their Association With Non-Invasive Visceral Adiposity Indices
- ClinicalTrials.gov ID
- NCT07204782
- Acronym / sponsor ID
- Visceral adiposity indices
- Conditions
- Diabete Mellitus
- Keywords
- cardiovascular risk scores, visceral adiposity indices, diabetes mellitus, VAT, LAP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients attending Assiut university
Key inclusion criteria (2 listed)
- Adult patients ≥40 years old attending the out patients clinics
- Patients diagnosed with type 2 diabetes mellitus
Key exclusion criteria (12 listed)
- Patient with a history of cardiovascular events
- Patient with type 1 diabetes or gestational diabetes.
- Pregnant women.
- Hypothyroidism,
- Cushing disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The correlation between cardiovascular risk scores and non-invasive visceral adiposity indices (such as LAP and VAI).
Time frame: 1 YEAR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 40445502Tawfik 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.
- Background: PubMed 40050939Wang 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.
- Background: PubMed 29884191Einarson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of elevated 10-year cardiovascular risk scores among patients with type 2 diabetes mellitus. (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07204782, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.