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

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 .

Study Overview

• Status: Recruiting
• Conditions: System; Lupus Erythematosus

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut University Hospital
    • Contact: Dean of hospital; Phone Number: 20882411900; Email: med@aun.edu.eg
    • Principal Investigator: Muhammad Abd-Erazek Ahmad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SLE with corticosteroid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who developed Steroid-induced diabetes mellitus	development of diabetes mellitus after corticosteroid therapy	up to 12 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who didn't develop steroid-induced diabetes mellitus	no development of diabetes mellitus after corticosteroid therapy	12 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 20, 2024

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Connective Tissue Diseases; Diabetes Mellitus; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SDM in SLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No