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Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

Primary Purpose

Hypopituitarism

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intravenous Infusion of Diclofenac Sodium
Intravenous Infusion of Placebo
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypopituitarism

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous Infusion of Diclofenac Sodium

Intravenous Infusion of Placebo

Arm Description

Intravenous Infusion of Diclofenac Sodium in healthy subjects.

Intravenous Infusion of Placebo (isotonic saline) in healthy subjects.

Outcomes

Primary Outcome Measures

Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 30 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 45 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 60 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 90 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 120 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma copeptin levels between baseline and 240 minutes after diclofenac/placebo administration
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 15 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 30 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 45 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 60 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 90 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 120 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma MR-proANP levels between baseline and 240 minutes after diclofenac/placebo administration
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.

Secondary Outcome Measures

Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 30 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 45 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 60 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 90 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 120 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in serum sodium levels between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 15 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 30 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 45 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 60 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 90 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 120 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Change in plasma MR-proADM levels between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in urine sodium levels between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in urine potassium levels between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine potassium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in urine osmolality between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine osmolality (mOsm/kg) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in resistance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis was evaluated by measuring resistance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in reactance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring reactance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in phase angle at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring phase angle (°) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Change in late-night salivary cortisol levels between 9 hours before and 15 hours after diclofenac/placebo administration
The influence the administration of intravenous diclofenac sodium, compared to placebo, on late-night salivary cortisol was evaluated by measuring late-night salivary cortisol (ng/ml) at 11 pm the day before diclofenac/placebo administration, and at 11 pm the day of diclofenac/placebo administration.

Full Information

First Posted
December 1, 2021
Last Updated
January 11, 2022
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT05188131
Brief Title
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
Official Title
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Infusion of Diclofenac Sodium
Arm Type
Experimental
Arm Description
Intravenous Infusion of Diclofenac Sodium in healthy subjects.
Arm Title
Intravenous Infusion of Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous Infusion of Placebo (isotonic saline) in healthy subjects.
Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion of Diclofenac Sodium
Intervention Description
Intravenous Infusion of Diclofenac Sodium is administered at the dose of 75 mg, diluted in 100 ml of isotonic saline, over 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion of Placebo
Intervention Description
Intravenous Infusion of Placebo (represented by 100 ml of isotonic saline) is administered over 15 minutes.
Primary Outcome Measure Information:
Title
Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 30 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 45 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 60 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 90 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 120 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Title
Change in plasma copeptin levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response of the antidiuretic axis to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 15 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 30 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 45 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 60 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 90 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 120 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proANP levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response of the natriuretic peptide system to the administration of intravenous diclofenac sodium, compared to placebo, is evaluated by measuring plasma MR-proANP (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Secondary Outcome Measure Information:
Title
Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 30 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 45 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 60 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 90 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 120 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Title
Change in serum sodium levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 15 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 15 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 15 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 30 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 30 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 30 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 45 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 45 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 45 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 60 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 60 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 60 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 90 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 90 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 90 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 120 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 120 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 120 minutes after diclofenac/placebo administration
Title
Change in plasma MR-proADM levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring plasma MR-proADM (pmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in urine sodium levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine sodium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in urine potassium levels between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine potassium (mmol/L) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in urine osmolality between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of glycometabolic and hydroelectrolyte biochemical balance was evaluated by measuring urine osmolality (mOsm/kg) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in resistance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis was evaluated by measuring resistance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in reactance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring reactance (Ohm) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in phase angle at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration
Description
The response to the administration of intravenous diclofenac sodium, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring phase angle (°) at baseline (0 minutes) and after 240 minutes from diclofenac/placebo administration.
Time Frame
From baseline (0 minutes) to 240 minutes after diclofenac/placebo administration
Title
Change in late-night salivary cortisol levels between 9 hours before and 15 hours after diclofenac/placebo administration
Description
The influence the administration of intravenous diclofenac sodium, compared to placebo, on late-night salivary cortisol was evaluated by measuring late-night salivary cortisol (ng/ml) at 11 pm the day before diclofenac/placebo administration, and at 11 pm the day of diclofenac/placebo administration.
Time Frame
From 9 hours before to 15 hours after diclofenac/placebo administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
AOU Città della Salute e della Scienza
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
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Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

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