Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- hypoglycemia
研究概览
简要总结
In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).
详细描述
The risk of hypoglycaemia in primary adrenal insufficiency (PAI) is well known but has been only few studied. It is explained by cortisol insufficiency. Only a few publications concerned this subject. The risk of hypoglycaemia seems to be increased during acute decompensation, following cessation of treatment and during fasting or delayed food intake. So, this risk would be increased during intermittent fasting such as the Ramadan fast. A previous study carried out in the endocrinology department of La Rabta University Hospital involving 30 subjects with secondary adrenal insufficiency who were monitored by continuous glucose monitoring (CGM) for 24 hours showed three cases of hypoglycaemia during intermittent fasting and no hypoglycaemia outside fasting. Studies assessing the risks of intermittent fasting concerned subjects with secondary adrenal insufficiency. No study assessed the risks of intermittent fasting in PAI. Furthermore, given the mineralocorticoid deficiency in PAI, there is also a risk of dehydration and hypotension.
Aims of the study:
Overall objective: to assess the risks of intermittent fasting in subjects with primary adrenal insufficiency.
Specific objectives:
- To assess the frequency of hypoglycaemia in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To assess the frequency of dehydration in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To study the factors associated with hypoglycaemia and dehydration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary adrenal insufficiency
- •Disease duration of at least one year
- •Substituted with hydrocortisone and fludrocortisone
- •Wishing to fast during the month of Ramadan 2024
排除标准
- •Diabetes mellitus
- •Renal insufficiency
- •Hepatic insufficiency
- •Cardiac insufficiency
- •Respiratory insufficiency
- •Use of hypoglycaemic agents
- •Use of diuretics
- •Use of glucocorticoids other than those prescribed for replacement
- •Poor control of the disease (asthenia, malaise, melanoderma, discontinuation of treatment, etc.)
- •Pregnancy
- •Breast-feeding.
结局指标
主要结局
hypoglycemia
时间窗: the fasting period from predawn to sunset (approximately 16 hours)
clinical signs or interstitial glucose lower than 2.8mmol/l
次要结局
- Dehydration(the fasting period from predawn to sunset (approximately 16 hours))