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Completed

NCT Number: NCT05188131

Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

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).

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Key information

Conditions

Hypopituitarism Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AOU Città della Salute e della Scienza

Turin, Piedmont, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intravenous Infusion of Diclofenac Sodium

Drug

Intravenous Infusion of Diclofenac Sodium is administered at the dose of 75 mg, diluted in 100 ml of isotonic saline, over 15 minutes.

Intravenous infusion of placebo

Drug

Intravenous Infusion of Placebo (represented by 100 ml of isotonic saline) is administered over 15 minutes.

Primary outcomes

  1. Change in plasma copeptin levels between baseline and 15 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  2. Change in plasma copeptin levels between baseline and 30 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  3. Change in plasma copeptin levels between baseline and 45 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  4. Change in plasma copeptin levels between baseline and 60 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  5. Change in plasma copeptin levels between baseline and 90 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  6. Change in plasma copeptin levels between baseline and 120 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  7. Change in plasma copeptin levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  8. Change in plasma MR-proANP levels between baseline and 15 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  9. Change in plasma MR-proANP levels between baseline and 30 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  10. Change in plasma MR-proANP levels between baseline and 45 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  11. Change in plasma MR-proANP levels between baseline and 60 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  12. Change in plasma MR-proANP levels between baseline and 90 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  13. Change in plasma MR-proANP levels between baseline and 120 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  14. Change in plasma MR-proANP levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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 outcomes

  1. Change in serum sodium levels between baseline and 15 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  2. Change in serum sodium levels between baseline and 30 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  3. Change in serum sodium levels between baseline and 45 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  4. Change in serum sodium levels between baseline and 60 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  5. Change in serum sodium levels between baseline and 90 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  6. Change in serum sodium levels between baseline and 120 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  7. Change in serum sodium levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  8. Change in plasma MR-proADM levels between baseline and 15 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  9. Change in plasma MR-proADM levels between baseline and 30 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  10. Change in plasma MR-proADM levels between baseline and 45 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  11. Change in plasma MR-proADM levels between baseline and 60 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  12. Change in plasma MR-proADM levels between baseline and 90 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  13. Change in plasma MR-proADM levels between baseline and 120 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  14. Change in plasma MR-proADM levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  15. Change in urine sodium levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  16. Change in urine potassium levels between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  17. Change in urine osmolality between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  18. Change in resistance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  19. Change in reactance at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  20. Change in phase angle at bioimpedance vector analysis between baseline and 240 minutes after diclofenac/placebo administration

    Time frame: From baseline (0 minutes) to 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.

  21. Change in late-night salivary cortisol levels between 9 hours before and 15 hours after diclofenac/placebo administration

    Time frame: From 9 hours before to 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.

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

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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