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

Primary Purpose

Thirst, Water-Electrolyte Imbalance

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Dulaglutide
Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thirst

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dulaglutide

Placebo

Arm Description

Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.

0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.

Outcomes

Primary Outcome Measures

Fluid intake
Fluid intake (ml) during an evaluation visit

Secondary Outcome Measures

Thirst
Thirst perception
Urine volume
Urine volume in ml
Urinary sodium
Urinary sodium excretion
Electrolytes
Plasma electrolytes
Urine electrolytes
Urine electrolytes
copeptin
copeptin values
renin
renin
aldosterone
aldosterone
Water and Salt
Brain Natriuretic Peptide (BNP)
GLP-1
GLP-1
Hypothalamus Pituitary Adrenal Axis (HPA)
cortisol value after Dexamethasone intake
circadian rhythm
circadian rhythm of serum cortisol
salivary cortisol
circadian rhythm of salivary cortisol
ACTH
circadian rhythm of ACTH
Hypothalamus Pituitary Adrenal Axis (HPA)
cortisol upon adrenocorticotropic hormone (ACTH) stimulation
Hypothalamus Pituitary Adrenal Axis (HPA)
free urinary cortisol

Full Information

First Posted
April 27, 2017
Last Updated
October 23, 2017
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03141632
Brief Title
Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
Acronym
GATE
Official Title
Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thirst, Water-Electrolyte Imbalance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, placebo control, cross-over design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind study
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dulaglutide
Arm Type
Active Comparator
Arm Description
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
Verum
Intervention Description
Evaluation visit with assessment of fluid intake
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Evaluation visit with assessment of fluid intake
Primary Outcome Measure Information:
Title
Fluid intake
Description
Fluid intake (ml) during an evaluation visit
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Thirst
Description
Thirst perception
Time Frame
8 hours
Title
Urine volume
Description
Urine volume in ml
Time Frame
24 hours
Title
Urinary sodium
Description
Urinary sodium excretion
Time Frame
24 hours
Title
Electrolytes
Description
Plasma electrolytes
Time Frame
3 timpoints during 8 hours
Title
Urine electrolytes
Description
Urine electrolytes
Time Frame
3 timpoints during 8 hours
Title
copeptin
Description
copeptin values
Time Frame
3 timpoints during 8 hours
Title
renin
Description
renin
Time Frame
3 timpoints during 8 hours
Title
aldosterone
Description
aldosterone
Time Frame
3 timpoints during 8 hours
Title
Water and Salt
Description
Brain Natriuretic Peptide (BNP)
Time Frame
3 timpoints during 8 hours
Title
GLP-1
Description
GLP-1
Time Frame
3 timpoints during 8 hours
Title
Hypothalamus Pituitary Adrenal Axis (HPA)
Description
cortisol value after Dexamethasone intake
Time Frame
8 hours after Dexamethasone intake
Title
circadian rhythm
Description
circadian rhythm of serum cortisol
Time Frame
16 hours
Title
salivary cortisol
Description
circadian rhythm of salivary cortisol
Time Frame
16 hours
Title
ACTH
Description
circadian rhythm of ACTH
Time Frame
16 hours
Title
Hypothalamus Pituitary Adrenal Axis (HPA)
Description
cortisol upon adrenocorticotropic hormone (ACTH) stimulation
Time Frame
0.5 hours
Title
Hypothalamus Pituitary Adrenal Axis (HPA)
Description
free urinary cortisol
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof
Organizational Affiliation
University Hospital fo Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35134170
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.
Results Reference
derived

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

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