Clinical trial NCT03141632: Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
Official title: Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thirst
Water-Electrolyte Imbalance
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo control, cross-over design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- Age 18 to 65 years

Exclusion Criteria:

* 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)
* Cancer

Primary outcomes:
measure: Fluid intake
timeFrame: 8 hours
Secondary outcomes:
measure: Thirst
timeFrame: 8 hours
measure: Urine volume
timeFrame: 24 hours
measure: Urinary sodium
timeFrame: 24 hours
measure: Electrolytes
timeFrame: 3 timpoints during 8 hours
measure: Urine electrolytes
timeFrame: 3 timpoints during 8 hours
measure: copeptin
timeFrame: 3 timpoints during 8 hours
measure: renin
timeFrame: 3 timpoints during 8 hours
measure: aldosterone
timeFrame: 3 timpoints during 8 hours
measure: Water and Salt
timeFrame: 3 timpoints during 8 hours
measure: GLP-1
timeFrame: 3 timpoints during 8 hours
measure: Hypothalamus Pituitary Adrenal Axis (HPA)
timeFrame: 8 hours after Dexamethasone intake
measure: circadian rhythm
timeFrame: 16 hours
measure: salivary cortisol
timeFrame: 16 hours
measure: ACTH
timeFrame: 16 hours
measure: Hypothalamus Pituitary Adrenal Axis (HPA)
timeFrame: 0.5 hours
measure: Hypothalamus Pituitary Adrenal Axis (HPA)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital fo Basel
name: Mirjam Christ-Crain, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vukajlovic T, Sailer CO, Asmar A, Jensen BL, Vogt DR, Christ-Crain M, Winzeler B. Effect of a 3-Week Treatment with GLP-1 Receptor Agonists on Vasoactive Hormones in Euvolemic Participants. J Clin Endocrinol Metab. 2022 May 17;107(6):e2581-e2589. doi: 10.1210/clinem/dgac063.