NCT06761820

Brief Summary

Evaluation of the effect of the Glycemic control on cardiac function in patients with type 2 diabetes mellitus

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

December 24, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

December 24, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • functional alteration of left ventricel

    Echocardiography for evaluation anatomical (chamber demision by M - mode) and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF before the study and follow up echo assessment 3 month after glycemic control.

    3 months

Interventions

Echo : for evaluation anatomical and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF by M-mode before the study and follow up echo assessment 3 months after glycemic control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiology and diabetes outpatients clinics, internal medicine. Assiut University hospital.

You may qualify if:

  • type 2 diabetic patients with heart diseases

You may not qualify if:

  • patients with type 1 diabetes mellitus
  • gestational DM
  • CKD patients requiring haemodialysis
  • Immune system disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Mohamed Hossam Hassan, Professor

    Assiut University

    STUDY CHAIR
  • Hanaa Mohamed Riad, Doctor (lecture)

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ramez Gamal Shawky, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 7, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01