Ramadan Fasting in Secondary Adrenal Insufficiency Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- number of fasted days
研究概览
简要总结
Intermittent Ramadan fasting was associated with a risk of complications in patients with adrenal insufficiency. A risk stratification with recommendations (lifestyle and drug adjustment) for fasting in these patients has been recently published. So, this prospective interventional study was carried out to evaluated these recommendations. Patients with secondary adrenal insufficiency and willing to fast Ramadan were included. Before Ramadan, patients underwent a clinical examination and were educated for lifestyle measures and the schedule of glucocorticoid replacement therapy was adjusted. The occurrence of complications and the number of fasted days during the month of Ramadan 2023 were reported and compared with those of Ramadan 2022.
详细描述
Intermittent fasting during the month of Ramadan is one of the five pillars of Islam and a sacred ritual for Muslims. Patients with chronic diseases seek advice from their physician and insist on fasting. A former study showed that 76.7% of adrenal insufficiency patients were exempted from fasting and 50.5% of them fasted against the advice of their physician. Few studies have assessed the risk of complications in adrenal insufficiency patients. The most frequently reported complications were asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%). Hypoglycaemia was detected by 24 hour-continuous glucose monitoring in 10% of fasting patients with secondary adrenal insufficiency (SAI). These complications were more frequent in patients with insufficient knowledge of the disease. A literature review was published 2021 and a risk stratification of patients with adrenal insufficiency and recommendations for patient education and therapeutic adjustment were proposed. However, no study has evaluated the effect of these measures on Ramadan fasting in SAI.
The objectives were to:
- compare the number of fasted days and the prevalence of complications during Ramadan fasting before (2022) and after therapeutic education and treatment adjustment (2023) in patients with SAI.
- determine the factors associated with complications during Ramadan fasting in SAI.
Methods:
Before the month of Ramadan 2023, patients meeting the inclusion criteria were enrolled. All patients signed a written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years
- •Secondary adrenal insufficiency patients
- •Substituted with glucocorticoids for more than one year.
- •Willing to fast during the month of Ramadan 2023
排除标准
- •cardiac insufficiency,
- •respiratory insufficiency,
- •hepatic insufficiency,
- •renal insufficiency (creatinine clearance < 60 ml/min/1.73m2),
- •advanced neoplasia,
- •undernutrition,
- •diabetes insipidus,
- •diabetes mellitus,
- •neuro-psychiatric disease,
- •infectious disease
- •chronic inflammatory disease,
- •hyperthyroidism,
- •uncontrolled hypothyroidism,
- •alcoholism,
- •diuretic intake,
- •glucocorticoid treatment for purposes other than substitution,
- •treatment with enzyme inducers,
- •pregnancy,
- •breastfeeding
- •consent withdrawn
- •study discontinuation.
研究组 & 干预措施
patients with secondary adrenal insufficiency
education and treatment adjustment
干预措施: education and drug adjustement (Behavioral)
结局指标
主要结局
number of fasted days
时间窗: one month
change in the number of fasted days
prevalence of complications
时间窗: one month
change in the prevalece of complications
次要结局
未报告次要终点