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Completed

NCT Number: NCT03141632

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

Evaluation visit with assessment of fluid intake

Other names: Verum

Placebo

Other

Evaluation visit with assessment of fluid intake

Primary outcomes

  1. Fluid intake

    Time frame: 8 hours

    Fluid intake (ml) during an evaluation visit

Secondary outcomes

  1. Thirst

    Time frame: 8 hours

    Thirst perception

  2. Urine volume

    Time frame: 24 hours

    Urine volume in ml

  3. Urinary sodium

    Time frame: 24 hours

    Urinary sodium excretion

  4. Electrolytes

    Time frame: 3 timpoints during 8 hours

    Plasma electrolytes

  5. Urine electrolytes

    Time frame: 3 timpoints during 8 hours

    Urine electrolytes

  6. copeptin

    Time frame: 3 timpoints during 8 hours

    copeptin values

  7. renin

    Time frame: 3 timpoints during 8 hours

    renin

  8. aldosterone

    Time frame: 3 timpoints during 8 hours

    aldosterone

  9. Water and Salt

    Time frame: 3 timpoints during 8 hours

    Brain Natriuretic Peptide (BNP)

  10. GLP-1

    Time frame: 3 timpoints during 8 hours

    GLP-1

  11. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame: 8 hours after Dexamethasone intake

    cortisol value after Dexamethasone intake

  12. circadian rhythm

    Time frame: 16 hours

    circadian rhythm of serum cortisol

  13. salivary cortisol

    Time frame: 16 hours

    circadian rhythm of salivary cortisol

  14. ACTH

    Time frame: 16 hours

    circadian rhythm of ACTH

  15. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame: 0.5 hours

    cortisol upon adrenocorticotropic hormone (ACTH) stimulation

  16. Hypothalamus Pituitary Adrenal Axis (HPA)

    Time frame: 24 hours

    free urinary cortisol

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: GATE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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