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The impact of dietary salt intake and kidney disease on aldosterone regulation

MINeralocorticoid Dysregulation in Chronic Kidney Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25169606
Enrollment
48
Registered
2014-01-10
Start date
2013-12-18
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension in chronic kidney disease (CKD) Urological and Genital Diseases Hypertension in chronic kidney disease (CKD)

Interventions

This is a mechanistic unblinded crossover study with patients acting as their own control. This study will include three age and sex matched groups of CKD, essential hypertension (HTN) and normal cont
24 patients with CKD, 12 patients with essential hypertension (and PCR <20 mg/mmol), and 12 normal controls. The CKD group will include patients with CKD stages 3 and 4 (eGFR 15-60 ml/min). There will
12 patients will have proteinuria (PCR =100 mg/mmol) and 12 patients will have no proteinuria (PCR <50 mg/mmol). Patients will be given a container in which to complete a 24-hour urine collection prio

Sponsors

NHS Greater Glasgow and Clyde (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals aged between 18 and 80 years 2. Individuals with capacity 3. Renal group: 3.1 Patients with CKD who attend the Western Infirmary renal unit and its satellite units CKD stage 3 and CKD stage 4 [decline in glomerular filtration rate (GFR) <5ml/min in preceding 6 months] 3.2 Proteinuric [polymerase chain reaction (PCR) =100mg/mmol] and non proteinuric (PCR <50mg/mmol) patients will be included 3.3 Patients' blood pressure (BP) should be controlled <160/90 mmHg (where applicable patients should be on a stable dose of antihypertensive for four weeks prior to consent for study) 4. Hypertensive group: 4.1 Patients who attend the hypertension clinic at Western Infirmary Glasgow (WIG) or Glasgow Royal Infirmary (GRI) 4.2 Patients' BP should be controlled <160/90 mmHg (where applicable patients should be on a stable dose of antihypertensive for four weeks prior to consent for study) 4.3 No significant proteinuria (PCR <20 mg/mmol)

Exclusion criteria

Exclusion criteria: 1. Individuals unable to give informed consent 2. Diabetes mellitus (possibility of type 4 renal tubular acidosis ? hyporeninaemic hypoaldosteronism) 3. Patients with nephrotic range proteinuria (PCR =300 mg/mmol) 4. Patients on aldosterone antagonist or direct renin inhibitor 5. Individuals pregnant or breast feeding 6. Patients with a history of Conn?s syndrome, Cushing?s disease or Addison?s disease 7. Patients who require maintenance corticosteroids or patients who have had corticosteroid treatment within 3 months prior to study commencing 8. Renal group - patients with progressive (decline in eGFR of >5 ml/min) renal disease in the six months leading up to study start date

Design outcomes

Primary

MeasureTime frame
Difference in urinary aldosterone (THALDO) excretion after dietary salt loading between the three groups of patients (CKD, hypertension and control) will be measured from urine samples using gas chromatography-mass spectrometry (GC-MS)

Secondary

MeasureTime frame
1. Difference in serum aldosterone levels in response to acute salt loading (modified saline suppression test) at baseline between the three groups of patients. 2. Difference in response to angiotensin II stimulation test (serum aldosterone measurements) between the groups in the low and high salt environment. This test will be carried out at study visit number 2 and study visit number 3. 3. Influence of dietary salt intake on level of muscle sympathetic nerve activity (MSNA). An intraneural recording of MSNA will be made using a tungsten microelectrode after dietary salt loading and dietary salt reduction. This will be carried out at study visit number 2 and study visit number 3 before the angiotensin II stimulation test.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026