Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Salt concentration taste threshold
研究概览
简要总结
This study looks at how hypertensive patients, with high levels of aldosterone (hyperaldosteronism) differ from hypertensive patients without hyperaldosteronism with regards to markers of salt appetite. It also looks at how salt appetite changes after treatment of hyperaldosteronism. Salt makes food taste good and when our bodies need salt our brains make us like salty food even more. A high salt diet contributes to hypertension and a low salt diet is an important aspect of the treatment of hypertension. Unfortunately patients find it difficult to adhere to a low salt diet. Aldosterone is produced by the adrenal glands, its release is stimulated by a salt need and it has been shown, in rodent models, to activate pathways in the brain which drive a salt appetite. Mice with enhanced activity of the aldosterone pathway in the brain become hypertensive due to increased salt intake. Hyperaldosteronism, in humans, results in hypertension. The contribution of salt appetite, as opposed to the effect of aldosterone on the kidney's retention of salt and other systems, is unknown. Human studies have shown that when a human has a salt appetite, the concentration at which they can detect the taste of salt reduces, they increase their preference for salty food, and they consume more salt.
When hyperaldosteronism is suspected in a hypertensive patient, they attend hospital for a day of investigations. Patient who are shown to have hyperaldosteronism have subsequent visits for imaging of their adrenals and sampling of blood from the adrenal vein to diagnose aldosterone producing adenomas (small tumours) which may be removed surgically, if not suitable for surgery, the hyperaldosteronism is treated with medication. This study will recruit hyperaldosteronism patients to investigate the effect of aldosterone on salt appetite by testing salt taste threshold, salt taste preference and intake before and after treatment.
详细描述
Aims
- To determine if hypertensive patients with primary hyperaldosteronism have a lower salt taste threshold and heightened preference for salty soup compared to hypertensive patients with secondary aldosterone levels and a healthy control reference group.
- To determine if treating primary hyperaldosteronism, with removal of aldosterone producing adrenal adenomas or medical blockade of aldosterone, results in changes in salt taste threshold and preference for salty soup.
STUDY DESIGN
This will be a non-interventional observational study examining a cohort of adult patients with hypertension under the care of Imperial College Healthcare NHS Trust who are being investigated and treated for primary hyperaldosteronism. No clinical intervention will occur as part of this study outside of their standard clinical practice. The schedule of events for each study will occur within 6 months.
Visit 1 This coincides with the saline infusion test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Non-smoker (ex-smokers allowed)
排除标准
- •Contra-indications for saline infusion test - severe uncontrolled hypertension, renal insufficiency, cardiac insufficiency, cardiac arrhythmia, or severe hypokalemia
- •Current smoker
- •Neurological disorder (moderate-severe traumatic brain injury, dementia)
- •Significant current or past medical or psychiatric history, or use of medications, that, in the opinion of the Investigators, contraindicates their participation, due to influence on outcome measures.
- •Patients lacking capacity or unable to consent
- •Inability to understand verbal explanations or written information given in English
- •Patients currently participating in an active CTIMP trial, or within 4 half-lives of last administration of CTIMP product
研究组 & 干预措施
hyperaldosteronism surgical treatment
Hypertensive patients with primary hypersldosteronism, treated with surgery
干预措施: adrenalectomy (Procedure)
hyperaldosteronism medical treatment
Hypertensive patients with primary hypersldosteronism, treated with aldosterone blockade.
干预措施: Aldosterone Antagonist (Drug)
结局指标
主要结局
Salt concentration taste threshold
时间窗: 6 months
Concentration of saline at which the salt taste is detected.
Ratings of salt liking and intensity across different salt concentrations
时间窗: 6 months
ratings of liking/wanting and intensity of soup containing differing concentrations of salt.
次要结局
- Rating of sour liking and intensity(6 months)
- Rating of sweet liking and intensity(6 months)