Ramadan Fasting Outcomes in Patients with Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- number of fasted days
研究概览
简要总结
Intermittent fasting in patients with adrenal insufficiency is associated with an increased risk of complications, such as dehydration. A recent study showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting. So, we are planning to carry out this prospective interventional study in patients with SAI and hypotension to evaluate the effect of treating hypotension with fludrocortisone on the risk of complications during fasting. Patients with secondary adrenal insufficiency and hypotension and who are willing to fast during Ramadan 2025 will be included. Before Ramadan, they will be treated with fludrocortisone at a dose of 50micg/day. The occurrence of complications and the number of fasted days during Ramadan 2025 will be reported and compared with those of Ramadan 2023.
详细描述
Intermittent fasting during Ramadan is practised by more than one billion people worldwide. Patients with adrenal insufficiency are at risk of complications during fasting. The most frequently reported complications were intense asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%) Chihaoui M, et al, Endocrine 2017;55:289-295. https://doi.org/10.1007/s12020-016-1186-0). A recent study showed that lifestyle measures and drug adjustment enabled more patients to fast and reduced the frequency of complications. It also showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688).
The objective of the study is to compare the number of fasted days and the prevalence of complications during Ramadan fasting in patients with SAI before (2023) and after the treatment of hypotension with fludrocortisone (2025).
Keywords: secondary adrenal insufficiency; intermittent fasting; complications; hypotension; fludrocortisone; quality of life
Type of study: Prospective, interventional, before/after study
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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.
- •Participated in the former study in
- •Willing to fast during the month of Ramadan 2025.
排除标准
- •cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding.
- •consent withdrawn, study discontinuation.
研究组 & 干预措施
Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d
Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/day during Ramadan fasting 2025.
干预措施: Fludrocortisone 0.1 Milligrams (mg) (Drug)
结局指标
主要结局
number of fasted days
时间窗: One month
Total days fasted during the month of Ramadan 2025
次要结局
- complications during fasting(One month)