Clinical trial NCT05188131: Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
Official title: Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypopituitarism
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The effects of acute administration of non-steroidal anti-inflammatory drugs (NSAIDs) on the neuroendocrine regulation of hydro-electrolytic metabolism are not precisely known to date.

Although the mechanism by which NSAIDs favor the antidiuretic action of vasopressin (AVP) in the kidney has been partially elucidated, their influence on the mechanisms responsible for regulating its secretion are less known. The interactions between NSAIDs and natriuretic peptides are also not entirely certain.

The present pharmacological research study therefore aims to investigate, in a cohort of healthy subjects, the acute effects of intravenous infusion of diclofenac sodium on the neuroendocrine regulation systems of water and salt balance (i.e. the antidiuretic axis and the system of natriuretic peptides).


Eligibility criteria: Inclusion Criteria:

- Any adult healthy subject (with age 20-50 years old) not meeting any of the exclusion criteria listed below

Exclusion Criteria:

* BMI \< 18.5 kg/m2 or \> 25 kg/m2
* Any active pharmacological treatment
* Pregnancy or breastfeeding
* History of polyuria/polydipsia syndrome
* History of dysionia
* History of peptic disease
* History of gastrointestinal bleeding
* History of kidney disease
* History of heart disease
* History of asthma
* Known allergy to NSAIDs
* Any current acute medical condition

Primary outcomes:
measure: Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 30 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 45 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 60 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 90 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 120 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
measure: Change in plasma copeptin levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 15 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 30 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 45 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 60 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 90 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 120 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proANP levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Secondary outcomes:
measure: Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 30 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 45 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 60 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 90 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 120 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
measure: Change in serum sodium levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 15 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 30 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 45 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 60 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 90 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 120 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
measure: Change in plasma MR-proADM levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in urine sodium levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in urine potassium levels between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in urine osmolality between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in resistance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in reactance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in phase angle at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
timeFrame: From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
measure: Change in late-night salivary cortisol levels between 9 hours before and 15 hours after diclofenac/placebo administration
timeFrame: From 9 hours before to 15 hours after diclofenac/placebo administration
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
state: Piemonte
Study officials:
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