Clinical trial NCT04847414: Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt
Official title: Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 97
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients diagnosed with diabetes within 3 years in Upper Egypt

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in HbA1C
timeFrame: 3 months
measure: change in BMI
timeFrame: 3 months
Secondary outcomes:
measure: HOMA-IR
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References: