NCT05874323

Brief Summary

Type I Diabetes Mellitus (TIDM) is a chronic metabolic disorder caused by the immune-mediated T-cell and macrophages that typically affects insulin-producing β-cells of Langerhans leading to cell destruction and absolute insulin deficiency. This study aimed to investigate the correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes mellitus in the Egyptian patients with the activity and the severity of the disease and to assess their association with inflammatory reactions in TIDM patients (IL-6, TNF-α). Also, this study investigated the relation between MiRNA-34, MiRNA-146, to TID severity and activity

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

May 13, 2023

Last Update Submit

August 20, 2023

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes

    correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes using the TaqMan genotyping assay in the study population. Tumor necrosis factor-alpha (TNF-α), interleukin (IL-6) serum levels, and clinical parameters were measured using the enzyme-linked immunosorbent assay (ELISA) technique.

    4 months

Secondary Outcomes (1)

  • the relation between MiRNA-34, MiRNA-146, to TID severity and activity.

    4 months

Study Arms (2)

Type I Diabetes Mellitus

EXPERIMENTAL

177 patients with Type I Diabetes Mellitus

Genetic: Detection of RAGE gene polymorphism (rs1800625)

Control

OTHER

include 177 Healthy Control Cases.

Genetic: Detection of RAGE gene polymorphism (rs1800625)

Interventions

Detection of RAGE gene polymorphism (rs1800625)GENETIC

Detection of RAGE gene polymorphism (rs1800625) By Molecular analysis (real time PCR)

ControlType I Diabetes Mellitus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<18 Years

You may not qualify if:

  • \> 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes and Endocrinology's

Cairo, 11817, Egypt

Location

Study Officials

  • Amal mohamed, professor

    national hepatology and Tropical medicine institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 13, 2023

First Posted

May 24, 2023

Study Start

January 1, 2023

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)