Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)

Conditions

• Primary Polydipsia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dulaglutide — DRUG
  Treatment with dulaglutide for 3 weeks.
• Placebo — DRUG
  Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.

Study Details

Glucagon like Peptide -1 (GLP-1) receptor agonists 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 might be of advantage in persons with an exaggerated thirst perception as is the case in patients with primary polydipsia.

Key Dates

Start date

Mar 31, 2016

Status verified

Jan 2020

Primary completion

May 17, 2019

Completion

Oct 7, 2019

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Verum first
  Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
• Placebo Comparator: Placebo first
  Placebo: 0.5 ml normal saline (0.9% sodium chloride \[0.9% sodium chloride (NaCl)\]), injection sc via syringe once weekly for 3 weeks.

Primary Outcome Measure

Fluid intake in ml [ Time Frame: 8 hours ]