Thirst, Water-Electrolyte Imbalance
Conditions
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.
Interventions
DRUGDulaglutide
Evaluation visit with assessment of fluid intake
OTHERPlacebo
Evaluation visit with assessment of fluid intake
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind study
Intervention model description
Double-blind, placebo control, cross-over design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid intake | 8 hours | Fluid intake (ml) during an evaluation visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine volume | 24 hours | Urine volume in ml |
| Urinary sodium | 24 hours | Urinary sodium excretion |
| Electrolytes | 3 timpoints during 8 hours | Plasma electrolytes |
| Urine electrolytes | 3 timpoints during 8 hours | Urine electrolytes |
| copeptin | 3 timpoints during 8 hours | copeptin values |
| renin | 3 timpoints during 8 hours | renin |
| Thirst | 8 hours | Thirst perception |
| Water and Salt | 3 timpoints during 8 hours | Brain Natriuretic Peptide (BNP) |
| GLP-1 | 3 timpoints during 8 hours | GLP-1 |
| Hypothalamus Pituitary Adrenal Axis (HPA) | 8 hours after Dexamethasone intake | cortisol value after Dexamethasone intake |
| circadian rhythm | 16 hours | circadian rhythm of serum cortisol |
| salivary cortisol | 16 hours | circadian rhythm of salivary cortisol |
| ACTH | 16 hours | circadian rhythm of ACTH |
| aldosterone | 3 timpoints during 8 hours | aldosterone |
Countries
Switzerland
Outcome results
None listed