Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04847414
• Other study ID #: Soh-Med-21-04-16
• Status: Active, not recruiting
• Start date: April 10, 2021
• Est. completion date: April 24, 2023

Study information

• Verified date: April 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of our work:

First aim: Classify patients with adult-onset diabetes according to the novel classification into new subgroups, depending on multiple variables related clinically to those patients.

Second aim: To identify the association between the new classification subgroups and the presence of common microvascular complications (retinopathy, nephropathy, and neuropathy), which can help in the early prediction of these complications and their early management.

Description:

We will conduct an observational cross-sectional study and cluster analysis for patients from different Diabetes clinics and tertiary centres located in different governorates in Upper Egypt. Our participants in this study will be divided into two groups:

1. The first group will be as a prospective group, All necessary examinations and investigations will be performed for every patient of this group during their clinic visit at the time of registration to this study.

2. The second group will be the retrospective group. Data for those patients will be collected from electronic records and/or paper records in collaboration with different diabetes centres and clinics scattered in Upper Egypt governorates. We will collect clinical and lab data as much as we can. All available data for this group at end of this study will be used in the clustering of this group.

Then we will use the above data from both groups to classify diabetic patients to the new clusters and to find the association between those clusters and the incidence of microvascular complications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 97 Years

Eligibility

Inclusion Criteria:

• Adult-onset DM type 2 diagnosed patients according to current ADA recommendations, aged <18 years old and within 3 years from the time of diagnosis.

Exclusion Criteria:

• 1- Patients diagnosed with Gestational DM or rare types of diabetes like monogenic diabetes types, such as maturity-onset diabetes of the young (MODY), diabetes secondary to steroid use, cystic fibrosis, hemochromatosis, and pancreatic diabetes according to ADA criteria.

2- Patients diagnosed with non-diabetic kidney diseases, such as chronic glomerulonephritis, vasculitis, polycystic kidney disease, and renal cancer or patients with a transplanted kidney were excluded from the analysis for diabetic kidney disease.

3- Patients diagnosed with retinopathy due to non-diabetic causes or diagnosed with neuropathy due to non-diabetic causes will be excluded from the analysis for diabetic retinopathy and neuropathy, respectively.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Diagnostic Test:
• HbA1C, other investigations
we will do some necessary investigations for prospective group

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1C	percent %	3 months
Primary	change in BMI	kg/m2	3 months
Secondary	HOMA-IR	calculated by HOMA calculator presented by Oxford University	6 months