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

Thirst Clinical Trial

— GATE  

Official title:

Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141632
• Other study ID #: GATE
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2017
• Last updated: October 23, 2017
• Start date: October 17, 2016
• Est. completion date: May 12, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 12, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thirst
• Water-Electrolyte Imbalance

Intervention

Drug:
• Dulaglutide
Evaluation visit with assessment of fluid intake

Other:
• Placebo
Evaluation visit with assessment of fluid intake

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid intake	Fluid intake (ml) during an evaluation visit	8 hours
Secondary	Thirst	Thirst perception	8 hours
Secondary	Urine volume	Urine volume in ml	24 hours
Secondary	Urinary sodium	Urinary sodium excretion	24 hours
Secondary	Electrolytes	Plasma electrolytes	3 timpoints during 8 hours
Secondary	Urine electrolytes	Urine electrolytes	3 timpoints during 8 hours
Secondary	copeptin	copeptin values	3 timpoints during 8 hours
Secondary	renin	renin	3 timpoints during 8 hours
Secondary	aldosterone	aldosterone	3 timpoints during 8 hours
Secondary	Water and Salt	Brain Natriuretic Peptide (BNP)	3 timpoints during 8 hours
Secondary	GLP-1	GLP-1	3 timpoints during 8 hours
Secondary	Hypothalamus Pituitary Adrenal Axis (HPA)	cortisol value after Dexamethasone intake	8 hours after Dexamethasone intake
Secondary	circadian rhythm	circadian rhythm of serum cortisol	16 hours
Secondary	salivary cortisol	circadian rhythm of salivary cortisol	16 hours
Secondary	ACTH	circadian rhythm of ACTH	16 hours
Secondary	Hypothalamus Pituitary Adrenal Axis (HPA)	cortisol upon adrenocorticotropic hormone (ACTH) stimulation	0.5 hours
Secondary	Hypothalamus Pituitary Adrenal Axis (HPA)	free urinary cortisol	24 hours