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Comorbidities in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

HBA1C

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

Urine analysis and urinary albumin-to-creatinine ratio

Serum creatinine and estimated glomerular filtration rate

Complete blood count

Thyroid-stimulating hormone

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

Electrocardiography (ECG)

Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound

About this trial

This is an interventional screening trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

type 2 DM

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with hypertension

Number of participants with dyslipidemia

Number of participants with renal disease

Number of participants with cardiac disease

Number of participants with thyroid disorder

Secondary Outcome Measures

Number of participants with controlled diabetes mellitus

Full Information

NCT ID

NCT05874141

First Posted

March 30, 2023

Last Updated

September 21, 2023

Sponsor

New Valley University

1. Study Identification

Unique Protocol Identification Number

NCT05874141

Brief Title

Comorbidities in Type 2 Diabetes Mellitus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 25, 2023 (Anticipated)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

type 2 DM

Arm Type

Other

Intervention Type

Diagnostic Test

Intervention Name(s)

HBA1C

Intervention Description

blood sample on EDTA

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

serum sample

Intervention Type

Diagnostic Test

Intervention Name(s)

Urine analysis and urinary albumin-to-creatinine ratio

Intervention Description

Morning urine sample

Intervention Type

Diagnostic Test

Intervention Name(s)

Serum creatinine and estimated glomerular filtration rate

Intervention Description

serum sample

Intervention Type

Diagnostic Test

Intervention Name(s)

Complete blood count

Intervention Description

blood sample on EDTA

Intervention Type

Diagnostic Test

Intervention Name(s)

Thyroid-stimulating hormone

Intervention Description

serum sample

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

serum sample

Intervention Type

Procedure

Intervention Name(s)

Electrocardiography (ECG)

Intervention Description

by electrocardiogram

Intervention Type

Procedure

Intervention Name(s)

Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound

Intervention Description

imaging

Primary Outcome Measure Information:

Title

Number of participants with hypertension

Time Frame