Image

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

Recruiting
18 - 75 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Study details

System; Lupus Erythematosus

NCT04024306

Assiut University

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.