Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
GATE
Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
1 other identifier
interventional
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2016
CompletedFirst Submitted
Initial submission to the registry
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2017
CompletedOctober 25, 2017
October 1, 2017
7 months
April 27, 2017
October 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fluid intake
Fluid intake (ml) during an evaluation visit
8 hours
Secondary Outcomes (16)
Thirst
8 hours
Urine volume
24 hours
Urinary sodium
24 hours
Electrolytes
3 timpoints during 8 hours
Urine electrolytes
3 timpoints during 8 hours
- +11 more secondary outcomes
Study Arms (2)
Dulaglutide
ACTIVE COMPARATORDulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Placebo
PLACEBO COMPARATOR0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- \- Age 18 to 65 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
Related Publications (1)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirjam Christ-Crain, Prof
University Hospital fo Basel
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind study
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2017
First Posted
May 5, 2017
Study Start
October 17, 2016
Primary Completion
May 1, 2017
Study Completion
May 12, 2017
Last Updated
October 25, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share