Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

Phase 2

Completed

• Conditions: Thirst; Water-Electrolyte Imbalance
• Interventions: Other: Placebo; Drug: Dulaglutide

• Registration Number: NCT03141632
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2016-10-17
• Study First Submitted: 2017-04-27
• Primary Completion: 2017-05
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Study Completion: 2017-05-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.
Dulaglutide	Dulaglutide	Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Fluid intake	8 hours	Fluid intake (ml) during an evaluation visit

Secondary Outcome Measures

Name	Time	Method
Thirst	8 hours	Thirst perception
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
aldosterone	3 timpoints during 8 hours	aldosterone
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)	24 hours	free urinary cortisol
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland