Comorbidities in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Diagnostic Test: HBA1C
* Diagnostic Test: Lipid profile, including total, LDL, and HDL cholesterol and Triglycerides
* Diagnostic Test: Urine analysis and urinary albumin-to-creatinine ratio
* Diagnostic Test: Serum creatinine and estimated glomerular filtration rate
* Diagnostic Test: Complete blood count
* Diagnostic Test: Thyroid-stimulating hormone
* Diagnostic Test: Serum iron, TIBC, Transferrin saturation and serum ferritin if needed
* Procedure: Electrocardiography (ECG)
* Procedure: Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound
* Procedure: Arterial duplex ultrasound of both lower limbs
* Diagnostic Test: Random blood glucose
* Diagnostic Test: AST, ALT, albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes. Exclusion Criteria: Patients with type 1 diabetes. Patients with secondary diabetes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: type 2 DM<br> | Diagnostic Test: HBA1C<br>* blood sample on EDTA<br>Diagnostic Test: Lipid profile, including total, LDL, and HDL cholesterol and Triglycerides<br>* serum sample<br>Diagnostic Test: Urine analysis and urinary albumin-to-creatinine ratio<br>* Morning urine sample<br>Diagnostic Test: Serum creatinine and estimated glomerular filtration rate<br>* serum sample<br>Diagnostic Test: Complete blood count<br>* blood sample on EDTA<br>Diagnostic Test: Thyroid-stimulating hormone<br>* serum sample<br>Diagnostic Test: Serum iron, TIBC, Transferrin saturation and serum ferritin if needed<br>* serum sample<br>Procedure: Electrocardiography (ECG)<br>* by electrocardiogram<br>Procedure: Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound<br>* imaging<br>Procedure: Arterial duplex ultrasound of both lower limbs<br>* imaging<br>Diagnostic Test: Random blood glucose<br>* serum sample<br>Diagnostic Test: AST, ALT, albumin<br>* serum sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |