- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05874141
Comorbidities in Type 2 Diabetes Mellitus
Comorbidities in Type 2 Diabetes Mellitus: An Observational Study in Kharga City, New Valley Governate, Egypt
Study Overview
Status
Conditions
Intervention / Treatment
- 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
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kharga Oasis
-
Al Khārjah, Kharga Oasis, Egypt, 72511
- New Valley University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with type 2 diabetes.
Exclusion Criteria:
- Patients with type 1 diabetes.
- Patients with secondary diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: type 2 DM
|
blood sample on EDTA
serum sample
Morning urine sample
serum sample
blood sample on EDTA
serum sample
serum sample
by electrocardiogram
imaging
imaging
serum sample
serum sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with hypertension
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with dyslipidemia
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with thyroid disorder
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Diabetic kidney disease
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Coronary heart disease
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Stroke
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Peripheral arterial disease
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Diabetic eye disease
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Peripheral neuropathy
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Liver disease
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Infections
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Number of participants with Cancer
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with controlled diabetes mellitus with correlation to the number of cormobidity
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
|
Correlate the presence of each co-morbidity with the extent of diabetes control
Time Frame: At time of inclusion in the study
|
At time of inclusion in the study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Cell Count
- Cytological Techniques
- Hematologic Tests
- Cell Physiological Phenomena
- Blood Physiological Phenomena
- Circulatory and Respiratory Physiological Phenomena
- Diagnostic Techniques, Urological
- Clinical Chemistry Tests
- Blood Cell Count
- Urinalysis
Other Study ID Numbers
- CODM2KNV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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