Comorbidities in Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: 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

• Registration Number: NCT05874141
• Lead Sponsor: New Valley University

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-24
• Study Start: 2023-11-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• Patients with type 2 diabetes.

Exclusion Criteria

1. Patients with type 1 diabetes.
2. Patients with secondary diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
type 2 DM	Random blood glucose	-
type 2 DM	HBA1C	-
type 2 DM	Urine analysis and urinary albumin-to-creatinine ratio	-
type 2 DM	Complete blood count	-
type 2 DM	Serum creatinine and estimated glomerular filtration rate	-
type 2 DM	Thyroid-stimulating hormone	-
type 2 DM	Arterial duplex ultrasound of both lower limbs	-
type 2 DM	Serum iron, TIBC, Transferrin saturation and serum ferritin if needed	-
type 2 DM	Lipid profile, including total, LDL, and HDL cholesterol and Triglycerides	-
type 2 DM	AST, ALT, albumin	-
type 2 DM	Electrocardiography (ECG)	-
type 2 DM	Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound	-

Primary Outcome Measures

Name	Time	Method
Number of participants with hypertension	At time of inclusion in the study
Number of participants with thyroid disorder	At time of inclusion in the study
Number of participants with Liver 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 Infections	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 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 Cancer	At time of inclusion in the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New Valley University; 🇪🇬 Kharga Oasis, Egypt