Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Hypoglycemia
研究概览
简要总结
In primary adrenal insufficiency (PAI), there is a risk of hypoglycemia and dehydration. These risks seem to be increased during intermittent fasting. A previous study in patients with PAI treated with hydrocortisone at a dose of 20 mg/day showed that the prevalence of hypoglycemia was as high outside (63%) as during Ramadan fasting (71%), and that there was no risk of dehydration. We propose to evaluate the risk of complications during and outside of Ramadan fasting through a prospective study with subjects taken as their own controls, in 35 patients with PAI treated with prednisolone at a dose of 5 mg/day. Patients will undergo an interview, physical examination, blood sampling, and continuous glucose monitoring (CGM) during two weeks of fasting and two weeks of non-fasting.
详细描述
The risk of hypoglycemia in adrenal insufficiency is known but poorly studied. It is due to cortisol deficiency. Only a few publications have addressed this topic. The risk of hypoglycemia is thought to be increased during acute decompensation, following treatment discontinuation, and during fasting or delayed eating. Thus, this risk is thought to be increased during intermittent fasting, such as the Ramadan fast. A previous study conducted in the endocrinology department of La Rabta Hospital, involving 30 subjects with corticotropic insufficiency who underwent 24-hour continuous glucose monitoring (CGM), identified three cases of hypoglycemia during intermittent fasting and no hypoglycemia outside of fasting periods. A more recent study showed that the prevalence of hypoglycemia, assessed by a seven day-CGM, was 63% outside of fasting and 71% during Ramadan fasting in subjects with PAI substituted with hydrocortisone at the usual dose of 20mg/day.
The most commonly used glucocorticoid replacement therapy is based on hydrocortisone or cortisone. Prednisolone is also indicated, particularly in cases difficult to control with hydrocortisone. The usual dose is 5 mg/day. It has been suggested to replace hydrocortisone with prednisolone to reduce the risk of complications during Ramadan fasting. However, this has never been demonstrated. A previous study showed that the prevalence of complications, quality of life, and point-in-time capillary blood glucose measurements were not different with hydrocortisone or prednisolone.
On the other hand, the risk of dehydration and hypotension seems to be low in patients treated with hydrocortisone.
General objective:
To evaluate the risks of intermittent fasting in subjects with PAI treated with prednisolone 5 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with primary adrenal insufficiency known for at least one year, treated with a glucocorticoid and a mineralocorticoid, who wish to fast during Ramadan 2026.
排除标准
- •presence of diabetes, renal, hepatic, cardiac, or respiratory insufficiency; use of hypoglycemic agents (sulfonylureas), diuretics, use of any glucocorticoid other than the prescribed replacement therapy; poor disease control (asthenia, malaise, hyperpigmentation, discontinuation of treatment, etc.); pregnancy; breastfeeding; menstruation.
研究组 & 干预措施
Outside Ramadan fasting
Patients with PAI treated with prednisolone 5mg/day, outside Ramadan fasting
Ramadan fasting
Patients with PAI treated with prednisolone 5mg/day during Ramadan fasting.
干预措施: Ramadan fasting (Other)
结局指标
主要结局
Hypoglycemia
时间窗: during 14 days before Ramdan fasting and 14 days of Ramdan fasting
Diagnosed using continuous glucose monitoring
Dehydration
时间窗: During the 14 days before Ramadan fasting and during the 14 days of Ramadan fasting.
Hypotension and increased serum urea
次要结局
未报告次要终点
研究者
Melika Chihaoui
Professor of Endocrinology, Faculty of Medicine of Tunis, University Tunis El Manar. Head of the Department of Endocrinology, University hospital La rabta, Tunis, Tunisia.
Hopital La Rabta