Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Fluid intake
研究概览
简要总结
The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in healthy volunteers compared to Placebo.
详细描述
GLP-1 analogues are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic properties of GLP-1 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind study
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
- 是
入选标准
- •Age 18 to 65 years
排除标准
- •Known or probable central or nephrogenic Diabetes insipidus, based on patient's history
- •Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
- •Primary Polydipsia, defined as more than 4 liters fluid intake per day
- •BMI <18 or >30kg/m2
- •Pregnancy
- •Previous treatment with GLP-1 agonists within the last 3 month
- •History of pancreatitis
- •Severe renal insufficiency (eGFR (CKD EPI) <30 ml/min/1,73 m2)
研究组 & 干预措施
Dulaglutide
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
干预措施: Dulaglutide (Drug)
Placebo
0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Fluid intake
时间窗: 8 hours
Fluid intake (ml) during an evaluation visit
次要结局
- Urine volume(24 hours)
- Urinary sodium(24 hours)
- Electrolytes(3 timpoints during 8 hours)
- Urine electrolytes(3 timpoints during 8 hours)
- copeptin(3 timpoints during 8 hours)
- renin(3 timpoints during 8 hours)
- Thirst(8 hours)
- aldosterone(3 timpoints during 8 hours)
- Water and Salt(3 timpoints during 8 hours)
- GLP-1(3 timpoints during 8 hours)
- Hypothalamus Pituitary Adrenal Axis (HPA)(24 hours)
- circadian rhythm(16 hours)
- salivary cortisol(16 hours)
- ACTH(16 hours)