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

NCT04847414 | Unknown DMC

• 1 other identifier: Soh-Med-21-04-16
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• change in HbA1C

  percent %

  3 months

• change in BMI

  kg/m2

  3 months

Secondary Outcomes (1)

• HOMA-IR

  6 months

Study Arms (2)

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

retrospective group

all needed data will be collected from medical records either electronic or paper based from different diabetes clinics in upper Egypt

Interventions

HbA1C, other investigations DIAGNOSTIC_TEST

we will do some necessary investigations for prospective group

prospective group

Eligibility Criteria

• Age: 18 Years - 97 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients diagnosed with diabetes within 3 years in Upper Egypt

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer, The principal investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: April 10, 2021
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)