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Completed

NCT Number: NCT05874141

Comorbidities in Type 2 Diabetes Mellitus

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Valley University

Al Khārjah, Kharga Oasis, 72511, Egypt

About this study

All-cause mortality rates have declined substantially in several high-income countries, including England.

A diversification in non-fatal conditions in people with DM has also been reported. This is attributable to broader, non-vascular conditions. Due to increasing longevity among people with type 2 DM with increasing and diversifying multimorbidity in them, the health needs of people with Type 2 DM are therefore likely to be broad, and complex.

Finding multimorbidity (two or more chronic conditions) is common in people with Type 2 DM and increasing, but the comorbidity profiles of people with T2DM vary substantially.

Many studies have primarily focused on identifying multimorbidity patterns in the general population.

The understanding of multimorbidity patterns and composition of specific comorbidities in people with DM, and how this varies across patient groups and during the course of the disease, is limited. Further knowledge of this could provide insight into providing more holistic and more personal approaches to clinical guideline development, care pathways, and secondary prevention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type 2 diabetes.

Exclusion criteria

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

Treatment and study plan

HBA1C

Diagnostic Test

blood sample on EDTA

Lipid profile, including total, LDL, and HDL cholesterol and Triglycerides

Diagnostic Test

serum sample

Urine analysis and urinary albumin-to-creatinine ratio

Diagnostic Test

Morning urine sample

Serum creatinine and estimated glomerular filtration rate

Diagnostic Test

serum sample

Complete blood count

Diagnostic Test

blood sample on EDTA

Thyroid-stimulating hormone

Diagnostic Test

serum sample

Serum iron, TIBC, Transferrin saturation and serum ferritin if needed

Diagnostic Test

serum sample

Electrocardiography (ECG)

Procedure

by electrocardiogram

Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound

Procedure

imaging

Arterial duplex ultrasound of both lower limbs

Procedure

imaging

Random blood glucose

Diagnostic Test

serum sample

AST, ALT, albumin

Diagnostic Test

serum sample

Primary outcomes

  1. Number of participants with hypertension

    Time frame: At time of inclusion in the study

  2. Number of participants with dyslipidemia

    Time frame: At time of inclusion in the study

  3. Number of participants with Diabetic kidney disease

    Time frame: At time of inclusion in the study

  4. Number of participants with Coronary heart disease

    Time frame: At time of inclusion in the study

  5. Number of participants with thyroid disorder

    Time frame: At time of inclusion in the study

  6. Number of participants with Stroke

    Time frame: At time of inclusion in the study

  7. Number of participants with Peripheral arterial disease

    Time frame: At time of inclusion in the study

  8. Number of participants with Diabetic eye disease

    Time frame: At time of inclusion in the study

  9. Number of participants with Peripheral neuropathy

    Time frame: At time of inclusion in the study

  10. Number of participants with Liver disease

    Time frame: At time of inclusion in the study

  11. Number of participants with Infections

    Time frame: At time of inclusion in the study

  12. Number of participants with Cancer

    Time frame: At time of inclusion in the study

Secondary outcomes

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

    Time frame: At time of inclusion in the study

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

    Time frame: At time of inclusion in the study

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

Comorbidities in Type 2 Diabetes Mellitus: An Observational Study in Kharga City, New Valley Governate, Egypt

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 24, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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