Comorbidities in Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874141
• Other study ID #: CODM2KNV
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: New Valley University
• Contact: Asmaa N Hussein, MD
• Phone: 01065161752
• Email: asmaanady_1010[@]med.nvu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes.

Exclusion Criteria:

1. Patients with type 1 diabetes.

2. Patients with secondary diabetes.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Diagnostic Test:
• HBA1C
blood sample on EDTA
• Lipid profile, including total, LDL, and HDL cholesterol and Triglycerides
serum sample
• Urine analysis and urinary albumin-to-creatinine ratio
Morning urine sample
• Serum creatinine and estimated glomerular filtration rate
serum sample
• Complete blood count
blood sample on EDTA
• Thyroid-stimulating hormone
serum sample
• Serum iron, TIBC, Transferrin saturation and serum ferritin if needed
serum sample

Procedure:
• Electrocardiography (ECG)
by electrocardiogram
• Transthoracic echocardiography, Neck ultrasonography if needed and abdominopelvic ultrasound
imaging
• Arterial duplex ultrasound of both lower limbs
imaging

Diagnostic Test:
• Random blood glucose
serum sample
• AST, ALT, albumin
serum sample

Locations

Country	Name	City	State
Egypt	New Valley University	Kharga Oasis

Sponsors (1)

Lead Sponsor	Collaborator
New Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with hypertension		At time of inclusion in the study
Primary	Number of participants with dyslipidemia		At time of inclusion in the study
Primary	Number of participants with Diabetic kidney disease		At time of inclusion in the study
Primary	Number of participants with Coronary heart disease		At time of inclusion in the study
Primary	Number of participants with thyroid disorder		At time of inclusion in the study
Primary	Number of participants with Stroke		At time of inclusion in the study
Primary	Number of participants with Peripheral arterial disease		At time of inclusion in the study
Primary	Number of participants with Diabetic eye disease		At time of inclusion in the study
Primary	Number of participants with Peripheral neuropathy		At time of inclusion in the study
Primary	Number of participants with Liver disease		At time of inclusion in the study
Primary	Number of participants with Infections		At time of inclusion in the study
Primary	Number of participants with Cancer		At time of inclusion in the study
Secondary	Number of participants with controlled diabetes mellitus with correlation to the number of cormobidity		At time of inclusion in the study
Secondary	Correlate the presence of each co-morbidity with the extent of diabetes control		At time of inclusion in the study