Primary PolydipsiaPhase 2GOLDNCT02770885
Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)
A Phase 2 study testing Dulaglutide in people with Primary Polydipsia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Polydipsia
- What is being tested?
- Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to 7 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Polyuria of > 50 ml/Kg/day
- Polydipsia of > 3 liters/day
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"
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.
Read the detailed 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.
- Conditions
- Primary Polydipsia
- Being tested
- Dulaglutide, Placebo
- Medical subject headings
- Polydipsia, Psychogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called Trulicity
Treatment with dulaglutide for 3 weeks.
PlaceboDrug
Also called Sodium Chloride 0.9%
Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Verum first | Experimental | Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid intake in ml
Fluid intake (ml) during an evaluation visit of 8 hours
Measured: 8 hours
Secondary outcomes (9)
Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire
To assess the influence of dulaglutide on thirst perception and quality of life in patients with primary polydipsia compared to placebo.
Measured: During phase a and b, 3 weeks each
24h-urine production
24h-urine production in ml during evaluation visit and thereafter
Measured: 24 hours
Plasma- and urine osmolality
influence of dulaglutide on osmolality during evaluation visit
Measured: change during evaluation visit of 8 hours
Circadian serum- and salivary cortisol levels
Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity
Measured: circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm
Cortisol levels basal and stimulated
Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity
Measured: Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection
Copeptin level
Influence of dulaglutide on copeptin levels after a period of water deprivation
Measured: at begin of evaluation 1 day visit after an overnight fast (no drink, no food)
Influence of dulaglutide on neuronal changes
Neuronal changes assessed with a functional magnet resonance Imaging between dulaglutide and Placebo Treatment in a subgroup of patients with primary polydipsia
Measured: during phase a and b, 3rd week each for 15 patients
Neuronal changes between patients with primary polydipsia and healthy volunteers
Differences in neuronal changes assessed by functional magnet resonance imaging
Measured: for patients during phase a and b, 3rd week each for 15 patients, 15 matched healthy control subjects
Thirst perception
Influence of dulaglutide on thirst perception
Measured: during phase a and b, 3 weeks each and change during evaluation visit of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMar 2016
- Primary completion17 May 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary PolydipsiaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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 of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770885
- Sponsor's protocol ID
- GOLD 2016
- Acronym
- GOLD
- Status last verified
- Jan 2020
- First submitted
- 30 Mar 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 35134170Winzeler 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.
PubMed 34473645
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"
- ClinicalTrials.gov ID
- NCT02770885
- Acronym / sponsor ID
- GOLD / GOLD 2016
- Conditions
- Primary Polydipsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum first | Experimental | Drug: DulaglutideDulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks. |
| Placebo first | Placebo comparator | Drug: PlaceboPlacebo: 0.5 ml normal saline (0.9% sodium chloride [0.9% sodium chloride (NaCl)]), injection sc via syringe once weekly for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Polyuria of > 50 ml/Kg/day
- Polydipsia of > 3 liters/day
Key exclusion criteria (7 listed)
- 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
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: TrulicityTreatment with dulaglutide for 3 weeks. | Drug | Verum first |
| PlaceboAlso: Sodium Chloride 0.9%Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks. | Drug | Placebo first |
Primary outcome
Fluid intake in ml
Time frame: 8 hours
Fluid intake (ml) during an evaluation visit of 8 hours
9 secondary outcomes
Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire
Time frame: During phase a and b, 3 weeks each
24h-urine production
Time frame: 24 hours
Plasma- and urine osmolality
Time frame: change during evaluation visit of 8 hours
Circadian serum- and salivary cortisol levels
Time frame: circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm
Cortisol levels basal and stimulated
Time frame: Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection
Copeptin level
Time frame: at begin of evaluation 1 day visit after an overnight fast (no drink, no food)
Influence of dulaglutide on neuronal changes
Time frame: during phase a and b, 3rd week each for 15 patients
Neuronal changes between patients with primary polydipsia and healthy volunteers
Time frame: for patients during phase a and b, 3rd week each for 15 patients, 15 matched healthy control subjects
Thirst perception
Time frame: during phase a and b, 3 weeks each and change during evaluation visit of 8 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 18 Jan 2020.
- 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.
- Derived from this study: PubMed 34473645Winzeler 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.
- Individual participant dataSharing planned: No
Related trials for Primary Polydipsia
Recruiting
Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
Arginine Vasopressin Deficiency, Primary Polydipsia
Not yet recruiting
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
Primary Polydipsia, Central Diabetes Insipidus
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 of 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 Primary Polydipsia, 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 3 inclusion and 7 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 18 Jan 2020. 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 in ml (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 NCT02770885, which also lists 2 linked publications.
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 18 Jan 2020.