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

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ClinicalTrials.gov Identifier: NCT02770885
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Primary Polydipsia Drug: Dulaglutide Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"
Study Start Date : March 2016
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : October 7, 2019


Arm Intervention/treatment
Experimental: Verum first
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
Drug: Dulaglutide
Treatment with dulaglutide for 3 weeks.
Other Name: Trulicity

Placebo Comparator: Placebo first
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
Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.
Other Name: Sodium Chloride 0.9%




Primary Outcome Measures :
  1. Fluid intake in ml [ Time Frame: 8 hours ]
    Fluid intake (ml) during an evaluation visit of 8 hours


Secondary Outcome Measures :
  1. Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire [ Time Frame: During phase a and b, 3 weeks each ]
    To assess the influence of dulaglutide on thirst perception and quality of life in patients with primary polydipsia compared to placebo.

  2. 24h-urine production [ Time Frame: 24 hours ]
    24h-urine production in ml during evaluation visit and thereafter

  3. Plasma- and urine osmolality [ Time Frame: change during evaluation visit of 8 hours ]
    influence of dulaglutide on osmolality during evaluation visit

  4. Circadian serum- and salivary cortisol levels [ Time Frame: circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm ]
    Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity

  5. Cortisol levels basal and stimulated [ Time Frame: Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection ]
    Influence of dulaglutide on hypothalamic-pituitary-adrenal axis (HPA axis) activity

  6. Copeptin level [ Time Frame: at begin of evaluation 1 day visit after an overnight fast (no drink, no food) ]
    Influence of dulaglutide on copeptin levels after a period of water deprivation

  7. Influence of dulaglutide on neuronal changes [ Time Frame: during phase a and b, 3rd week each for 15 patients ]
    Neuronal changes assessed with a functional magnet resonance Imaging between dulaglutide and Placebo Treatment in a subgroup of patients with primary polydipsia

  8. 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 ]
    Differences in neuronal changes assessed by functional magnet resonance imaging

  9. Thirst perception [ Time Frame: during phase a and b, 3 weeks each and change during evaluation visit of 8 hours ]
    Influence of dulaglutide on thirst perception



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770885


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Mirjam Christ-Crain, Prof University Hospital of Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02770885    
Other Study ID Numbers: GOLD 2016
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Insipidus
Polydipsia
Polydipsia, Psychogenic
Pathologic Processes
Behavioral Symptoms
Neurobehavioral Manifestations
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs