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

University Hospital Basel logo

University Hospital Basel

Status and phase

Completed
Phase 2

Conditions

Water-Electrolyte Imbalance
Thirst

Treatments

Other: Placebo
Drug: Dulaglutide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

17 participants in 2 patient groups, including a placebo group

Dulaglutide
Active Comparator group
Description:
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Treatment:
Drug: Dulaglutide
Placebo
Placebo Comparator group
Description:
0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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