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临床试验/NCT04024306
NCT04024306招募中不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Number of patients who developed Steroid-induced diabetes mellitus

研究概览

简要总结

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 .

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of patients who developed Steroid-induced diabetes mellitus

时间窗: up to 12 months post-randomization

development of diabetes mellitus after corticosteroid therapy

次要结局

  • Number of patients who didn't develop steroid-induced diabetes mellitus(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Abd-Erazek Ahmad

Assiut, Egypt

Assiut University

研究点 (1)

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