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

Recruiting

• Conditions: System; Lupus Erythematosus

• Registration Number: NCT04024306
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Study Start: 2022-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients who developed Steroid-induced diabetes mellitus	up to 12 months post-randomization	development of diabetes mellitus after corticosteroid therapy

Secondary Outcome Measures

Name	Time	Method
Number of patients who didn't develop steroid-induced diabetes mellitus	12 months	no development of diabetes mellitus after corticosteroid therapy

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt