ThirstPhase 2GATENCT03141632
Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
A Phase 2 study testing Dulaglutide in people with Thirst and Water-Electrolyte Imbalance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thirst, Water-Electrolyte Imbalance
- What is being tested?
- Dulaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2016to 12 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
Who cannot join
- 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
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- History of pancreatitis
- Severe renal insufficiency (eGFR (CKD EPI) <30 ml/min/1,73 m2)
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
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.
Read the detailed description
GLP-1 analogues 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 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.
- Conditions
- Thirst, Water-Electrolyte Imbalance
- Being tested
- Dulaglutide, Placebo
- Medical subject headings
- Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called Verum
Evaluation visit with assessment of fluid intake
PlaceboOther
Evaluation visit with assessment of fluid intake
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide | Active comparator | Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks. Receives: Drug: Dulaglutide |
| Placebo | Placebo comparator | 0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid intake
Fluid intake (ml) during an evaluation visit
Measured: 8 hours
Secondary outcomes (16)
Thirst
Thirst perception
Measured: 8 hours
Urine volume
Urine volume in ml
Measured: 24 hours
Urinary sodium
Urinary sodium excretion
Measured: 24 hours
Electrolytes
Plasma electrolytes
Measured: 3 timpoints during 8 hours
Urine electrolytes
Urine electrolytes
Measured: 3 timpoints during 8 hours
copeptin
copeptin values
Measured: 3 timpoints during 8 hours
renin
renin
Measured: 3 timpoints during 8 hours
aldosterone
aldosterone
Measured: 3 timpoints during 8 hours
Water and Salt
Brain Natriuretic Peptide (BNP)
Measured: 3 timpoints during 8 hours
GLP-1
GLP-1
Measured: 3 timpoints during 8 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
cortisol value after Dexamethasone intake
Measured: 8 hours after Dexamethasone intake
circadian rhythm
circadian rhythm of serum cortisol
Measured: 16 hours
salivary cortisol
circadian rhythm of salivary cortisol
Measured: 16 hours
ACTH
circadian rhythm of ACTH
Measured: 16 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
cortisol upon adrenocorticotropic hormone (ACTH) stimulation
Measured: 0.5 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
free urinary cortisol
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start17 Oct 2016
- Primary completionMay 2017
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThirstStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo control, cross-over design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof, Principal investigator, University Hospital fo Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141632
- Sponsor's protocol ID
- GATE
- Acronym
- GATE
- Status last verified
- Oct 2017
- First submitted
- 27 Apr 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35134170
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"
- ClinicalTrials.gov ID
- NCT03141632
- Acronym / sponsor ID
- GATE / GATE
- Conditions
- Thirst, Water-Electrolyte Imbalance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GLP-1 analogues 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 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo control, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide | Active comparator | Drug: DulaglutideDulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks. |
| Placebo | Placebo comparator | Other: Placebo0.5 ml normal saline (0.9% sodium chloride), sc once weekly for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 65 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideAlso: VerumEvaluation visit with assessment of fluid intake | Drug | Dulaglutide |
| PlaceboEvaluation visit with assessment of fluid intake | Other | Placebo |
Primary outcome
Fluid intake
Time frame: 8 hours
Fluid intake (ml) during an evaluation visit
16 secondary outcomes
Thirst
Time frame: 8 hours
Urine volume
Time frame: 24 hours
Urinary sodium
Time frame: 24 hours
Electrolytes
Time frame: 3 timpoints during 8 hours
Urine electrolytes
Time frame: 3 timpoints during 8 hours
copeptin
Time frame: 3 timpoints during 8 hours
renin
Time frame: 3 timpoints during 8 hours
aldosterone
Time frame: 3 timpoints during 8 hours
Water and Salt
Time frame: 3 timpoints during 8 hours
GLP-1
Time frame: 3 timpoints during 8 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
Time frame: 8 hours after Dexamethasone intake
circadian rhythm
Time frame: 16 hours
salivary cortisol
Time frame: 16 hours
ACTH
Time frame: 16 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
Time frame: 0.5 hours
Hypothalamus Pituitary Adrenal Axis (HPA)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 35134170Vukajlovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, Prof principal investigator
University Hospital fo Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dulaglutide in people with Thirst and Water-Electrolyte Imbalance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid intake (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.