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

System; Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024306
• Other study ID #: SDM in SLE
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: April 20, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 20, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Lupus Erythematosus, Systemic
• System; Lupus Erythematosus

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who developed Steroid-induced diabetes mellitus	development of diabetes mellitus after corticosteroid therapy	up to 12 months post-randomization
Secondary	Number of patients who didn't develop steroid-induced diabetes mellitus	no development of diabetes mellitus after corticosteroid therapy	12 months