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Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients

Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04024306
Enrollment
120
Registered
2019-07-18
Start date
2022-09-01
Completion date
2024-04-20
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

System; Lupus Erythematosus

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 .

Detailed description

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. Diagnosis of DM will be made according to the American Diabetes Association(29), that is fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5 or 2-h plasma glucose ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). SLE patients who receive corticosteroids treatment will be screened with fasting blood sugar during out-patient clinic visit. If fasting blood glucose level is high , an additional HbA1C or OGTT will be performed. All patients included in this study will be subjected to: 1. Full history taking: including age, sex, duration of the SLE disease , age at onset of symptoms of SLE, the progression of disease, type of corticosteroid used, dosage, duration of treatment and other types of drugs used, presence of hypertension, dyslipidemia, smoking. 2. Complete clinical examination: A standardized physical examination will be performed in all patients to measure blood pressure, waist circumference and body mass index. 3. Laboratory investigations: * Fasting plasma glucose. * HbA1c. * 2-h plasma glucose. * Total cholesterol, triglyceride, low density lipoprotein (LDL) and high density lipoprotein (HDL) levels.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who developed Steroid-induced diabetes mellitusup to 12 months post-randomizationdevelopment of diabetes mellitus after corticosteroid therapy

Secondary

MeasureTime frameDescription
Number of patients who didn't develop steroid-induced diabetes mellitus12 monthsno development of diabetes mellitus after corticosteroid therapy

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026