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

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Primary Polydipsia

Treatments: Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT02770885

GOLD 2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Verum first

Experimental group

Description:

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

Treatment:

Drug: Dulaglutide

Placebo first

Placebo Comparator group

Description:

Placebo: 0.5 ml normal saline (0.9% sodium chloride \[0.9% sodium chloride (NaCl)\]), injection sc via syringe once weekly for 3 weeks.

Treatment:

Drug: Placebo