NCT05102851

Brief Summary

Diabetes mellitus is one of the chronic non-communicable diseases which have emerged as a leading global health problem. According to the International Diabetes Federation Atlas guideline report, currently, there are 352 million adults with impaired glucose tolerance who are at high risk of developing diabetes in the future. In 2017, it was estimated that 425 million people (20-79 years of age) suffered from Diabetes mellitus, and the number is expected to rise to 629 million by 2045. Moreover, Egypt is considered one of the top 10 countries in the world

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

August 31, 2022

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

August 18, 2021

Last Update Submit

August 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hba1c

    We consider patients with Hba1c less than 5.7% not diabetic , Patients with Hba1c from 5.7%-6.4% prediabetic and patients with Hba1c 6.5% or more diabetic patients

    Day 1

  • CCU admission

    All patients admitted with acute coronary syndrome will be included in the research

    6 months

Study Arms (1)

Patient with acute coronary syndrome

All patients with the acute coronary syndrome were included in the study. Pre-diabetic patient. Non-diabetic patient(Controlled)

Diagnostic Test: Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index

Interventions

Full history: age, sex, smoking, known diabetes, positive family history high serum creatinine, history of prior percutaneous coronary intervention (PCI) or coronary arteries bypass grafting (CABG), or acute coronary syndrome (ACS). hypertension, diet.

Patient with acute coronary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Statistical presentation and analysis of the present study will be conducted SPSS V.22. Data will be expressed into phases: Ι- Descriptive Mean value(X) and Standard Deviation (SD): for quantitative data. Frequency and percentage for qualitative data. Π- Analytic by t-student test and Chi-square test. P value \>0.05 will be considered statistically non-significant. P value ≤0.05 will be considered statistically significant. P value ≤0.001 will be considered statistically highly significant. Variance: Correlation of MPV with other parameters was performed by Pearson correlation test (r value as the coefficient).

You may qualify if:

  • All patients with acute coronary syndrome
  • Diabetic patients and will be subdivided into controlled and uncontrolled Pre-diabetic patients.
  • Non-diabetic patient(Controlled)

You may not qualify if:

  • Patient under 18 years old
  • Pregnancy
  • Chronic kidney disease
  • Familiar hyperlipidemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Diabetic Cardiomyopathies

Interventions

Body Mass Index

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Amal K. Ahmed, Ass. Prof.

    Sohag University

    STUDY DIRECTOR
  • Hany A. Muhammed Khalil, Lecturer

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at Internal Medicine department, Sohag University Hospital

Study Record Dates

First Submitted

August 18, 2021

First Posted

November 2, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 23, 2022

Last Updated

August 31, 2022

Record last verified: 2021-07

Locations