NCT02770885

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

March 30, 2016

Last Update Submit

January 16, 2020

Conditions

Primary Polydipsia

Outcome Measures

Primary Outcomes (1)

  • Fluid intake in ml

    Fluid intake (ml) during an evaluation visit of 8 hours

    8 hours

Secondary Outcomes (9)

  • Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire

    During phase a and b, 3 weeks each

  • 24h-urine production

    24 hours

  • Plasma- and urine osmolality

    change during evaluation visit of 8 hours

  • Circadian serum- and salivary cortisol levels

    circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm

  • Cortisol levels basal and stimulated

    Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection

  • +4 more secondary outcomes

Study Arms (2)

Verum first

EXPERIMENTAL

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

Drug: Dulaglutide

Placebo first

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DulaglutideDRUG

Treatment with dulaglutide for 3 weeks.

Also known as: Trulicity
Verum first
PlaceboDRUG

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

Also known as: Sodium Chloride 0.9%
Placebo first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Related Publications (2)

  • Vukajlovic T, Sailer CO, Asmar A, Jensen BL, Vogt DR, Christ-Crain M, Winzeler B. Effect of a 3-Week Treatment with GLP-1 Receptor Agonists on Vasoactive Hormones in Euvolemic Participants. J Clin Endocrinol Metab. 2022 May 17;107(6):e2581-e2589. doi: 10.1210/clinem/dgac063.

    PMID: 35134170DERIVED

  • Winzeler B, Sailer CO, Coynel D, Zanchi D, Vogt DR, Urwyler SA, Refardt J, Christ-Crain M. A randomized controlled trial of the GLP-1 receptor agonist dulaglutide in primary polydipsia. J Clin Invest. 2021 Oct 15;131(20):e151800. doi: 10.1172/JCI151800.

    PMID: 34473645DERIVED

MeSH Terms

Conditions

Polydipsia, Psychogenic

Interventions

dulaglutideSodium Chloride

Condition Hierarchy (Ancestors)

PolydipsiaPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mirjam Christ-Crain, Prof

    University Hospital of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

May 12, 2016

Study Start

March 1, 2016

Primary Completion

May 17, 2019

Study Completion

October 7, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)