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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04847414
Enrollment
1000
Registered
2021-04-19
Start date
2021-04-10
Completion date
2023-04-24
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTHbA1C, other investigations

we will do some necessary investigations for prospective group

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 97 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in HbA1C3 monthspercent %
change in BMI3 monthskg/m2

Secondary

MeasureTime frameDescription
HOMA-IR6 monthscalculated by HOMA calculator presented by Oxford University

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026