Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan. : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- HbA1c Level after ramadan
研究概览
简要总结
This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Participants were randomly assigned to three groups: Control (usual care), Education Only, and Education plus Coaching. All received a 30-minute pre-Ramadan education session; the Education plus Coaching group also had follow-up telephone consultations. Outcomes included HbA1c, fasting blood glucose, cholesterol, BMI, and blood pressure measured before and after Ramadan. The study aims to assess whether structured education and ongoing coaching help patients fast safely and maintain better metabolic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.
排除标准
- •Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
结局指标
主要结局
HbA1c Level after ramadan
时间窗: From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019
the level of HbA1c after ramadan
HbA1c level after ramadan
时间窗: 6 to 8 weeks
次要结局
未报告次要终点
研究者
Imen Zemni
Medical Doctor
University of Monastir