Skip to content

Trial · Interventional

CompletedPhase 2Registry data

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

Short name GATE

NCTNCT03141632 (opens ClinicalTrials.gov in a new tab)Other idGATE
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
17 participants (actual)
Sponsor
University Hospital, Basel, Switzerland · Other
Design
Randomized · Quadruple masking
Countries
1 country

Switzerland

Start
17 Oct 2016
Primary completion
May 2017
Completion
12 May 2017
First posted
5 May 2017
Last update posted
25 Oct 2017
Conditions
Thirst · Water-Electrolyte Imbalance

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    GATE

    NCT03141632

    17 Oct 2016 to 12 May 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DulaglutideDrug
  • PlaceboOther

Arms2

  • Active comparator

    Dulaglutide

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fluid intake

    Time frame · 8 hours

    Registry description

    Fluid intake (ml) during an evaluation visit

Secondary outcomes(16)

  1. Thirst

    Time frame · 8 hours

    Registry description

    Thirst perception

  2. Urine volume

    Time frame · 24 hours

    Registry description

    Urine volume in ml

  3. Urinary sodium

    Time frame · 24 hours

    Registry description

    Urinary sodium excretion

  4. Electrolytes

    Time frame · 3 timpoints during 8 hours

    Registry description

    Plasma electrolytes

  5. Urine electrolytes

    Time frame · 3 timpoints during 8 hours

    Registry description

    Urine electrolytes

  6. copeptin

    Time frame · 3 timpoints during 8 hours

    Registry description

    copeptin values

  7. renin

    Time frame · 3 timpoints during 8 hours

    Registry description

    renin

  8. aldosterone

    Time frame · 3 timpoints during 8 hours

    Registry description

    aldosterone

  9. Water and Salt

    Time frame · 3 timpoints during 8 hours

    Registry description

    Brain Natriuretic Peptide (BNP)

  10. GLP-1

    Time frame · 3 timpoints during 8 hours

    Registry description

    GLP-1

  11. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame · 8 hours after Dexamethasone intake

    Registry description

    cortisol value after Dexamethasone intake

  12. circadian rhythm

    Time frame · 16 hours

    Registry description

    circadian rhythm of serum cortisol

  13. salivary cortisol

    Time frame · 16 hours

    Registry description

    circadian rhythm of salivary cortisol

  14. ACTH

    Time frame · 16 hours

    Registry description

    circadian rhythm of ACTH

  15. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame · 0.5 hours

    Registry description

    cortisol upon adrenocorticotropic hormone (ACTH) stimulation

  16. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame · 24 hours

    Registry description

    free urinary cortisol

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

7 results

Effect of a 3-Week Treatment with GLP-1 Receptor Agonists on Vasoactive Hormones in Euvolemic Participants.

Vukajlovic et al. 2022The Journal of clinical endocrinology and metabolismcited by 3

PMID 35134170DOI 10.1210/clinem/dgac063PUB-35134170

Rights unknown7 results
Source linkSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.