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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-10-07

Brief Summary

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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.

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Detailed Description

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GLP-1 analogues are currently used for the treatment of hyperglycaemia associated with type 2 diabetes mellitus and given his properties as a natural satiety hormone, the GLP-1 analogue liraglutide was recently approved by the FDA for weight management.

In studies related to the influence of GLP-1 and -analogues in controlling food intake a concomitant reduction of fluid consumption has been observed.

The investigators hypothesize that GLP-1 analogues not only modulate appetite and provide satiety but also reduce fluid intake and thirst sensation in humans - especially in those with excessive thirst perception (patients with primary polydipsia). In view of future therapeutic options for these patients we aim to investigate the influence of the long-acting GLP-1 analogue dulaglutide on fluid intake, thirst perception and quality of life in patients with primary polydipsia compared to placebo.

Conditions

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Primary Polydipsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum first

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

Group Type EXPERIMENTAL

Dulaglutide

Intervention Type DRUG

Treatment with dulaglutide for 3 weeks.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.

Interventions

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Dulaglutide

Treatment with dulaglutide for 3 weeks.

Intervention Type DRUG

Placebo

Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.

Intervention Type DRUG

Other Intervention Names

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Trulicity Sodium Chloride 0.9%

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years
* Polyuria of \> 50 ml/Kg/day
* Polydipsia of \> 3 liters/day

Exclusion Criteria

* Known or probable central or nephrogenic Diabetes insipidus, expected from patient's history
* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No