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

What Was Tested

This registered phase 2 trial tested Dulaglutide.

It had two arms (groups): Verum first (experimental) and Placebo first (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In view of future therapeutic options for these patients the researchers 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 Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age over 18 years. Polydipsia of \> 3 liters/day.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: known or probable central or nephrogenic diabetes insipidus, expected from patient's history; polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia; previous treatment with glp-1 agonists within the last 3 month.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Each person switched between Dulaglutide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Dulaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-03 with completion listed for 2019-05-17.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fluid intake in ml (time frame: 8 hours).

It also tracked 9 secondary outcomes, for example Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire, 24h-urine production, Plasma- and urine osmolality, Circadian serum- and salivary cortisol levels, Cortisol levels basal and stimulated and Copeptin level.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.