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
About this trial
This is an interventional diagnostic trial for Hypopituitarism
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
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
NCT ID
NCT05188131
First Posted
December 1, 2021
Last Updated
January 11, 2022
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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
Citations:
PubMed Identifier
8443484
Citation
Cheung NT, Coley S, Sheeran T, Situnayake RD. Syndrome of inappropriate secretion of antidiuretic hormone induced by diclofenac. BMJ. 1993 Jan 16;306(6871):186. doi: 10.1136/bmj.306.6871.186-a. No abstract available.
Results Reference
background
PubMed Identifier
23624139
Citation
Verrua E, Mantovani G, Ferrante E, Noto A, Sala E, Malchiodi E, Iapichino G, Peccoz PB, Spada A. Severe water intoxication secondary to the concomitant intake of non-steroidal anti-inflammatory drugs and desmopressin: a case report and review of the literature. Hormones (Athens). 2013 Jan-Mar;12(1):135-41. doi: 10.1007/BF03401295.
Results Reference
background
PubMed Identifier
23840216
Citation
Roche C, Ragot C, Moalic JL, Simon F, Oliver M. Ibuprofen can induce syndrome of inappropriate diuresis in healthy young patients. Case Rep Med. 2013;2013:167267. doi: 10.1155/2013/167267. Epub 2013 Jun 12.
Results Reference
background
PubMed Identifier
29043122
Citation
Lim SY, Panikkath R, Prabhakar S. Syndrome of inappropriate antidiuretic hormone secretion associated with prolonged keterolac use. Clin Nephrol Case Stud. 2014 Jan 22;2:5-8. doi: 10.5414/CNCS108083. eCollection 2014.
Results Reference
background
PubMed Identifier
24569125
Citation
Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar. Erratum In: Eur J Endocrinol. 2014 Jul;171(1):X1.
Results Reference
background
PubMed Identifier
12388460
Citation
Murase T, Tian Y, Fang XY, Verbalis JG. Synergistic effects of nitric oxide and prostaglandins on renal escape from vasopressin-induced antidiuresis. Am J Physiol Regul Integr Comp Physiol. 2003 Feb;284(2):R354-62. doi: 10.1152/ajpregu.00065.2002. Epub 2002 Oct 10.
Results Reference
background
PubMed Identifier
22238766
Citation
Babina AV, Lavrinenko VA, Shestopalova LV, Ivanova LN. Morphological characteristics of the inner medullary zone in the kidneys of Brattleboro and Wistar rats during blockade of prostaglandin synthesis. Bull Exp Biol Med. 2011 Jun;151(2):268-72. doi: 10.1007/s10517-011-1305-0.
Results Reference
background
PubMed Identifier
22803175
Citation
Lavrinenko VA, Babina AV, Shestopalova LV, Beizel NF, Ivanova LN. Effects of sodium diclofenac on the concentration function in animals with different neurohypophyseal status. Bull Exp Biol Med. 2012 Apr;152(6):728-30. doi: 10.1007/s10517-012-1617-8. English, Russian.
Results Reference
background
PubMed Identifier
27783283
Citation
Babina AV, Lavrinenko VA. Electron Microscopic Study of the Inner Medulla in Rat Kidneys under Conditions of Vasopressin Treatment Combined with Prostaglandin Synthesis Blockade. Bull Exp Biol Med. 2016 Oct;161(6):850-852. doi: 10.1007/s10517-016-3527-7. Epub 2016 Oct 25.
Results Reference
background
PubMed Identifier
27909962
Citation
Lavrinenko VA, Babina AV. Efficiency of Osmotic Concentration after Combined Treatment with Vasopressin and Blockage of Prostaglandin Synthesis. Bull Exp Biol Med. 2016 Dec;162(2):187-190. doi: 10.1007/s10517-016-3572-2. Epub 2016 Dec 2.
Results Reference
background
PubMed Identifier
29501264
Citation
Palmer BF, Clegg DJ. Altered Prostaglandin Signaling as a Cause of Thiazide-Induced Hyponatremia. Am J Kidney Dis. 2018 Jun;71(6):769-771. doi: 10.1053/j.ajkd.2017.11.026. Epub 2018 Feb 28. No abstract available.
Results Reference
background
PubMed Identifier
6094207
Citation
Puurunen J, Leppaluoto J. Centrally administered PGE2 inhibits gastric secretion in the rat by releasing vasopressin. Eur J Pharmacol. 1984 Sep 3;104(1-2):145-50. doi: 10.1016/0014-2999(84)90381-9.
Results Reference
background
PubMed Identifier
1778241
Citation
Bojanowska E, Guzek JW. Inhibition of prostaglandin synthesis and the release of vasopressin and oxytocin from the rat neurohypophysis: in vitro studies. Exp Clin Endocrinol. 1991;98(3):213-21. doi: 10.1055/s-0029-1211120.
Results Reference
background
PubMed Identifier
6404183
Citation
Walker BR. Suppressed basal antidiuretic hormone release during cyclooxygenase inhibition in conscious dogs. Am J Physiol. 1983 Apr;244(4):R487-91. doi: 10.1152/ajpregu.1983.244.4.R487.
Results Reference
background
PubMed Identifier
27879483
Citation
Heida JE, Boesten LSM, Ettema EM, Muller Kobold AC, Franssen CFM, Gansevoort RT, Zittema D. Comparison of ex vivo stability of copeptin and vasopressin. Clin Chem Lab Med. 2017 Jun 27;55(7):984-992. doi: 10.1515/cclm-2016-0559.
Results Reference
background
PubMed Identifier
16269513
Citation
Morgenthaler NG, Struck J, Alonso C, Bergmann A. Assay for the measurement of copeptin, a stable peptide derived from the precursor of vasopressin. Clin Chem. 2006 Jan;52(1):112-9. doi: 10.1373/clinchem.2005.060038. Epub 2005 Nov 3.
Results Reference
background
PubMed Identifier
1826370
Citation
Castellani S, Del Rosso A, Chen JL, Camaiti A, Carnovali M, Masotti G. The renal excretory activity of atrial natriuretic factor is independent of renal prostaglandins in humans. Prostaglandins Leukot Essent Fatty Acids. 1991 Jan;42(1):23-9. doi: 10.1016/0952-3278(91)90062-a.
Results Reference
background
PubMed Identifier
6204854
Citation
Vlaskovska M, Hertting G, Knepel W. Adrenocorticotropin and beta-endorphin release from rat adenohypophysis in vitro: inhibition by prostaglandin E2 formed locally in response to vasopressin and corticotropin-releasing factor. Endocrinology. 1984 Sep;115(3):895-903. doi: 10.1210/endo-115-3-895.
Results Reference
background
PubMed Identifier
3007904
Citation
Okajima T, Heldt R, Hertting G. Functional compartmentalization of arginine-vasopressin-activated cyclic AMP in anterior pituitary gland: the presence of a compartment activated by prostaglandin E2. Life Sci. 1986 Mar 24;38(12):1143-9. doi: 10.1016/0024-3205(86)90251-1.
Results Reference
background
PubMed Identifier
206852
Citation
Thompson ME, Hedge GA. Inhibition of corticotropin secretion by hypothalamic administration of indomethacin. Neuroendocrinology. 1978;25(4):212-20. doi: 10.1159/000122743.
Results Reference
background
PubMed Identifier
30974817
Citation
Lukaski HC, Vega Diaz N, Talluri A, Nescolarde L. Classification of Hydration in Clinical Conditions: Indirect and Direct Approaches Using Bioimpedance. Nutrients. 2019 Apr 10;11(4):809. doi: 10.3390/nu11040809.
Results Reference
background
Learn more about this trial
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
We'll reach out to this number within 24 hrs