Trial · Interventional
CompletedPhase 2Registry dataShort name GOLD
Switzerland
1 trial · 1 completed
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Verum first
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Placebo comparator
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.
Outcomes the sponsor listed as primary.
Fluid intake in ml
Time frame · 8 hours
Fluid intake (ml) during an evaluation visit of 8 hours
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
Influence of dulaglutide on neuronal changes
Time frame · during phase a and b, 3rd week each for 15 patients
Neuronal changes assessed with a functional magnet resonance Imaging between dulaglutide and Placebo Treatment in a subgroup of patients with primary polydipsia
Neuronal changes between patients with primary polydipsia and healthy volunteers
Time frame · for patients during phase a and b, 3rd week each for 15 patients, 15 matched healthy control subjects
Differences in neuronal changes assessed by functional magnet resonance imaging
Thirst perception
Time frame · during phase a and b, 3 weeks each and change during evaluation visit of 8 hours
Influence of dulaglutide on thirst perception
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2022
Vukajlovic et al. 2022The Journal of clinical endocrinology and metabolismcited by 3
PMID 35134170DOI 10.1210/clinem/dgac063PUB-35134170
Indexing hint: Randomized controlled trial · 2021
Winzeler et al. 2021The Journal of clinical investigationcited by 27
PMID 34473645PMC8516458DOI 10.1172/jci151800PUB-34473645
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