Comorbidities in Type 2 Diabetes Mellitus

NCT ID: NCT05874141

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-08-30

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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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type 2 DM

Group Type OTHER

HBA1C

Intervention Type DIAGNOSTIC_TEST

blood sample on EDTA

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

Intervention Type DIAGNOSTIC_TEST

serum sample

Urine analysis and urinary albumin-to-creatinine ratio

Intervention Type DIAGNOSTIC_TEST

Morning urine sample

Serum creatinine and estimated glomerular filtration rate

Intervention Type DIAGNOSTIC_TEST

serum sample

Complete blood count

Intervention Type DIAGNOSTIC_TEST

blood sample on EDTA

Thyroid-stimulating hormone

Intervention Type DIAGNOSTIC_TEST

serum sample

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

Intervention Type DIAGNOSTIC_TEST

serum sample

Electrocardiography (ECG)

Intervention Type PROCEDURE

by electrocardiogram

Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound

Intervention Type PROCEDURE

imaging

Arterial duplex ultrasound of both lower limbs

Intervention Type PROCEDURE

imaging

Random blood glucose

Intervention Type DIAGNOSTIC_TEST

serum sample

AST, ALT, albumin

Intervention Type DIAGNOSTIC_TEST

serum sample

Interventions

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HBA1C

blood sample on EDTA

Intervention Type DIAGNOSTIC_TEST

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

serum sample

Intervention Type DIAGNOSTIC_TEST

Urine analysis and urinary albumin-to-creatinine ratio

Morning urine sample

Intervention Type DIAGNOSTIC_TEST

Serum creatinine and estimated glomerular filtration rate

serum sample

Intervention Type DIAGNOSTIC_TEST

Complete blood count

blood sample on EDTA

Intervention Type DIAGNOSTIC_TEST

Thyroid-stimulating hormone

serum sample

Intervention Type DIAGNOSTIC_TEST

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

serum sample

Intervention Type DIAGNOSTIC_TEST

Electrocardiography (ECG)

by electrocardiogram

Intervention Type PROCEDURE

Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound

imaging

Intervention Type PROCEDURE

Arterial duplex ultrasound of both lower limbs

imaging

Intervention Type PROCEDURE

Random blood glucose

serum sample

Intervention Type DIAGNOSTIC_TEST

AST, ALT, albumin

serum sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes.

Exclusion Criteria

1. Patients with type 1 diabetes.
2. Patients with secondary diabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nady Hussein

Lecturer of Internal Medicine and Clinical Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New Valley University

Al Khārjah, Kharga Oasis, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Asmaa N Hussein, MD

Role: CONTACT

01065161752

Facility Contacts

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Asmaa N Hussein, MD

Role: primary

01065161752

References

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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.

Reference Type BACKGROUND
PMID: 31518657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29784146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27208325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33549162 (View on PubMed)

Other Identifiers

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CODM2KNV

Identifier Type: -

Identifier Source: org_study_id

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