Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging

NCT06930300 | Completed

• 1 other identifier: 2025-00474
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP. Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing. Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age. This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.

Conditions

Healthy Ageing

Outcome Measures

Primary Outcomes (1)

• Range of Variation in Copeptin

  The primary outcome is the range of variation in copeptin, i.e. difference of suppressed copeptin to the stimulated copeptin, in healthy elderly participants compared to young controls.

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

Secondary Outcomes (22)

• Changes in Copeptin upon stimulation and suppression

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

• Differences in total body water (L) measured by body impedance analysis

  at Baseline

• Changes in cortisol (mmol/L)

  Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

• Changes in blood pressure (mmHg)

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

Study Arms (2)

Stimulation first, Suppression second

EXPERIMENTAL

Other: Hypertonic 3% saline; Other: Water

Suppression first, Stimulation second

EXPERIMENTAL

Other: Hypertonic 3% saline; Other: Water

Interventions

Hypertonic 3% saline OTHER

Participants receive 10 ml/kg body weight of 3% saline infused over 1 hour. The aim is to stimulate copeptin release.

Stimulation first, Suppression second; Suppression first, Stimulation second

Water OTHER

Participants ingest 20 ml/kg water over 1h. The aim is to suppress copeptin release.

Stimulation first, Suppression second; Suppression first, Stimulation second

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-30 years or ≥ 60 years
• Normonatremia (135-145 mmol/L)
• Plasma osmolality 280-300 mOsm/kg
• BMI ≥18 and ≤ 30 kg/m2

You may not qualify if:

• Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.)
• Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy
• Pacemaker or ICD
• History of thrombosis
• Active oncologic disease
• Heart failure
• Liver cirrhosis
• Estimated glomerular filtration rate (eGFR) \< 60 ml/kg/1.73 m2
• Uncontrolled hypertension \>160 mmHg systolic or \>100 mmHg diastolic
• Polydipsia (ingestion of \>3L fluids per day) and polyuria (\>50 ml/kg urine production within 24 hours)
• Pregnancy or breastfeeding
• Participation in a study with investigational drugs within 30 days
• Acute illness
• Inability to follow study procedures

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Sodium Chloride; Water

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: April 30, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CH (1)