Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study) (GOLD)
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|ClinicalTrials.gov Identifier: NCT02770885|
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Polydipsia||Drug: Dulaglutide Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 17, 2019|
|Actual Study Completion Date :||October 7, 2019|
Experimental: Verum first
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Treatment with dulaglutide for 3 weeks.
Other Name: Trulicity
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.
Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.
Other Name: Sodium Chloride 0.9%
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770885
|University Hospital Basel|
|Principal Investigator:||Mirjam Christ-Crain, Prof||University Hospital of Basel|