NCT05874141

Brief Summary

Type 2 diabetes mellitus (DM) has adopted a top priority as it is a disease with an increasing prevalence. The number of people living with DM has increased more than fourfold over the past 40 years to more than 460 million people today

Trial Health

77
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
4mo left

Started Nov 2023

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
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 Progress89%
Nov 2023Aug 2026

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

March 30, 2023

Last Update Submit

August 12, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (12)

  • Number of participants with hypertension

    At time of inclusion in the study

  • Number of participants with dyslipidemia

    At time of inclusion in the study

  • Number of participants with Diabetic kidney disease

    At time of inclusion in the study

  • Number of participants with Coronary heart disease

    At time of inclusion in the study

  • Number of participants with thyroid disorder

    At time of inclusion in the study

  • Number of participants with Stroke

    At time of inclusion in the study

  • Number of participants with Peripheral arterial disease

    At time of inclusion in the study

  • Number of participants with Diabetic eye disease

    At time of inclusion in the study

  • Number of participants with Peripheral neuropathy

    At time of inclusion in the study

  • Number of participants with Liver disease

    At time of inclusion in the study

  • Number of participants with Infections

    At time of inclusion in the study

  • Number of participants with Cancer

    At time of inclusion in the study

Secondary Outcomes (2)

  • Number of participants with controlled diabetes mellitus with correlation to the number of cormobidity

    At time of inclusion in the study

  • Correlate the presence of each co-morbidity with the extent of diabetes control

    At time of inclusion in the study

Study Arms (1)

type 2 DM

OTHER
Diagnostic Test: HBA1CDiagnostic Test: Lipid profile, including total, LDL, and HDL cholesterol and TriglyceridesDiagnostic Test: Urine analysis and urinary albumin-to-creatinine ratioDiagnostic Test: Serum creatinine and estimated glomerular filtration rateDiagnostic Test: Complete blood countDiagnostic Test: Thyroid-stimulating hormoneDiagnostic Test: Serum iron, TIBC, Transferrin saturation and serum ferritin if neededProcedure: Electrocardiography (ECG)Procedure: Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasoundProcedure: Arterial duplex ultrasound of both lower limbsDiagnostic Test: Random blood glucoseDiagnostic Test: AST, ALT, albumin

Interventions

HBA1CDIAGNOSTIC_TEST

blood sample on EDTA

type 2 DM
Lipid profile, including total, LDL, and HDL cholesterol and TriglyceridesDIAGNOSTIC_TEST

serum sample

type 2 DM
Urine analysis and urinary albumin-to-creatinine ratioDIAGNOSTIC_TEST

Morning urine sample

type 2 DM
Serum creatinine and estimated glomerular filtration rateDIAGNOSTIC_TEST

serum sample

type 2 DM
Complete blood countDIAGNOSTIC_TEST

blood sample on EDTA

type 2 DM
Thyroid-stimulating hormoneDIAGNOSTIC_TEST

serum sample

type 2 DM
Serum iron, TIBC, Transferrin saturation and serum ferritin if neededDIAGNOSTIC_TEST

serum sample

type 2 DM
Electrocardiography (ECG)PROCEDURE

by electrocardiogram

type 2 DM
Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasoundPROCEDURE

imaging

type 2 DM
Arterial duplex ultrasound of both lower limbsPROCEDURE

imaging

type 2 DM
Random blood glucoseDIAGNOSTIC_TEST

serum sample

type 2 DM
AST, ALT, albuminDIAGNOSTIC_TEST

serum sample

type 2 DM

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes.

You may not qualify if:

  • Patients with type 1 diabetes.
  • Patients with secondary diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Valley University

Al Khārjah, Kharga Oasis, 72511, Egypt

RECRUITING

Related Publications (4)

  • Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

    PMID: 31518657BACKGROUND

  • Gregg EW, Cheng YJ, Srinivasan M, Lin J, Geiss LS, Albright AL, Imperatore G. Trends in cause-specific mortality among adults with and without diagnosed diabetes in the USA: an epidemiological analysis of linked national survey and vital statistics data. Lancet. 2018 Jun 16;391(10138):2430-2440. doi: 10.1016/S0140-6736(18)30314-3. Epub 2018 May 18.

    PMID: 29784146BACKGROUND

  • Harding JL, Shaw JE, Peeters A, Davidson S, Magliano DJ. Age-Specific Trends From 2000-2011 in All-Cause and Cause-Specific Mortality in Type 1 and Type 2 Diabetes: A Cohort Study of More Than One Million People. Diabetes Care. 2016 Jun;39(6):1018-26. doi: 10.2337/dc15-2308. Epub 2016 Apr 26.

    PMID: 27208325BACKGROUND

  • Pearson-Stuttard J, Bennett J, Cheng YJ, Vamos EP, Cross AJ, Ezzati M, Gregg EW. Trends in predominant causes of death in individuals with and without diabetes in England from 2001 to 2018: an epidemiological analysis of linked primary care records. Lancet Diabetes Endocrinol. 2021 Mar;9(3):165-173. doi: 10.1016/S2213-8587(20)30431-9. Epub 2021 Feb 4.

    PMID: 33549162BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

UrinalysisBlood Cell Count

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative TechniquesCell CountCytological TechniquesHematologic TestsCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Asmaa N Hussein, MD

CONTACT

01065161752asmaanady_1010@med.nvu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine and Clinical Hematology

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 24, 2023

Study Start

November 15, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)