NCT04024306

Brief Summary

The aim of the study is to determine the prevalence of steroid-induced diabetes mellitus (SDM) among systemic lupus erythematosus (SLE) patients and identify and assess the associated risk factors .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 16, 2019

Last Update Submit

July 18, 2023

Conditions

System; Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Number of patients who developed Steroid-induced diabetes mellitus

    development of diabetes mellitus after corticosteroid therapy

    up to 12 months post-randomization

Secondary Outcomes (1)

  • Number of patients who didn't develop steroid-induced diabetes mellitus

    12 months

Study Arms (1)

SLE with corticosteroid therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

120 SLE patients who attend the SLE and Rheumatology Clinic will be recruited into the study. All patients need to fulfil at least four criteria from the American College of Rheumatology Classification Criteria for SLE 1997(28). All patients need to be receiving corticosteroid therapy. SDM cases is defined as the development of DM after commencement of steroid treatment. Prevalent cases of SDM will also be included in the study.

You may qualify if:

  • Both males and females
  • Patients aged of 18-75 years.
  • Clinically diagnosed as SLE patients.
  • Receiving corticosteroid therapy.
  • Prevalent cases of SDM with SLE.

You may not qualify if:

  • SLE patients who do not receive corticosteroid therapy.
  • SLE patients with other types of diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut, Egypt

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 18, 2019

Study Start

September 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 20, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

EG(1)