Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fluid intake in ml
研究概览
简要总结
Glucagon like Peptide -1 (GLP-1) receptor agonists 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 might be of advantage in persons with an exaggerated thirst perception as is the case in patients with primary polydipsia.
详细描述
GLP-1 analogues are currently used for the treatment of hyperglycaemia associated with type 2 diabetes mellitus and given his properties as a natural satiety hormone, the GLP-1 analogue liraglutide was recently approved by the FDA for weight management.
In studies related to the influence of GLP-1 and -analogues in controlling food intake a concomitant reduction of fluid consumption has been observed.
The investigators hypothesize that GLP-1 analogues not only modulate appetite and provide satiety but also reduce fluid intake and thirst sensation in humans - especially in those with excessive thirst perception (patients with primary polydipsia). In view of future therapeutic options for these patients we aim to investigate the influence of the long-acting GLP-1 analogue dulaglutide on fluid intake, thirst perception and quality of life in patients with primary polydipsia compared to placebo.
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)
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
- •Age over 18 years
- •Polyuria of > 50 ml/Kg/day
- •Polydipsia of > 3 liters/day
排除标准
- •Known or probable central or nephrogenic Diabetes insipidus, expected from patient's history
- •Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
- •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
Verum first
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 first
Placebo: 0.5 ml normal saline (0.9% sodium chloride [0.9% sodium chloride (NaCl)]), injection sc via syringe once weekly for 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Fluid intake in ml
时间窗: 8 hours
Fluid intake (ml) during an evaluation visit of 8 hours
次要结局
- Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire(During phase a and b, 3 weeks each)
- 24h-urine production(24 hours)
- Plasma- and urine osmolality(change during evaluation visit of 8 hours)
- Circadian serum- and salivary cortisol levels(circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm)
- Cortisol levels basal and stimulated(Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection)
- Copeptin level(at begin of evaluation 1 day visit after an overnight fast (no drink, no food))
- Influence of dulaglutide on neuronal changes(during phase a and b, 3rd week each for 15 patients)
- Neuronal changes between patients with primary polydipsia and healthy volunteers(for patients during phase a and b, 3rd week each for 15 patients, 15 matched healthy control subjects)
- Thirst perception(during phase a and b, 3 weeks each and change during evaluation visit of 8 hours)