Clinical Trial: Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University Hospital, Basel, Switzerland
Current Primary Outcome: Fluid intake in ml [ Time Frame: 8 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire [ Time Frame: During phase a and b, 3 weeks each ]To assess the influence of dulaglutide on thirst perception and quality of life in patients with primary polydipsia compared to placebo.
- 24h-urine production [ Time Frame: 24 hours ]24h-urine production in ml during evaluation visit and thereafter
- Plasma- and urine osmolality [ Time Frame: change during evaluation visit of 8 hours ]influence of dulaglutide on osmolality during evaluation visit
- Circadian serum- and salivary cortisol levels [ Time Frame: circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm ]Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity
- Cortisol levels basal and stimulated [ Time Frame: Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection ]Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity
- Copeptin level [ Time Frame: at begin of evaluation 1 day visit after an overnight fast (no drink, no food) ]Influence of dulaglutide on copeptin levels after a period of water deprivation
Original Secondary Outcome: Same as current
Information By: University Hospital, Basel, Switzerland
Dates:
Date Received: March 30, 2016
Date Started: March 2016
Date Completion: May 2018
Last Updated: November 17, 2016
Last Verified: November 2016