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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Diagnostic test: HbA1C, other investigations

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult patients diagnosed with diabetes within 3 years in Upper Egypt

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prospective group; all needed data will be collected from patients in this group through performing full medical examination and doing all necessary investigations for them	Diagnostic test: HbA1C, other investigations; we will do some necessary investigations for prospective group
retrospective group; all needed data will be collected from medical records either electronic or paper based from different diabetes clinics in upper Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in HbA1C	percent %	3 months
change in BMI	kg/m2	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	calculated by HOMA calculator presented by Oxford University	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Anticipated): April 24, 2023
• Study Completion (Anticipated): April 24, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Soh-Med-21-04-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: sharing final results only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No