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NCT Number: NCT02770885

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.

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Key information

Conditions

Primary Polydipsia Behavior Behavioral Symptoms Pathologic Processes Pathological Conditions, Signs and Symptoms Polydipsia Polydipsia, Psychogenic Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Basel

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

Treatment with dulaglutide for 3 weeks.

Other names: Trulicity

Placebo

Drug

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

Other names: Sodium Chloride 0.9%

Primary outcomes

  1. Fluid intake in ml

    Time frame: 8 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: GOLD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 12, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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