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Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method

Consistency of 24-hour Urinary Aldosterone on on the Second Day and the Third Day in Diagnosis of Primary Aldosteronism Measured in the Oral Sodium Loading Test by Liquid Chromatography-tandem Mass Spectrometry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06750172
Enrollment
33
Registered
2024-12-27
Start date
2023-12-15
Completion date
2024-12-25
Last updated
2024-12-27

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

Conditions

Primary Aldosteronism

Keywords

diagnose, the oral sodium loading test

Brief summary

To compare the consistency of 24-hour urinary aldosterone in the diagnosis of primary aldosteronism by oral sodium loading test between the second day method and the third day method

Detailed description

This is an exploratory and prospective study of 17 healthy controls and 15 patients with primary aldosteronism, in which each participant will receive a high-sodium diet for 3 days to conduct a confirmatory test for primary aldosteronism. The consistency between the 2-day and 3-day oral sodium loading test for the diagnosis of primary aldosteronism is compared by measuring the 24-hour urinary aldosterone levels of the participants on the second and third days of the high-sodium diet. The study aims to explore whether the 24-hour urinary aldosterone level on the second day can replace the 24-hour urinary aldosterone level on the third day for the diagnosis of primary aldosteronism.

Interventions

The subjects underwent an oral high-salt diet test with an additional 10g of salt per day for 3 consecutive days, and 24-hour urine measurements of aldosterone, sodium, potassium and creatinine were obtained on days 2 and 3

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

PA patients: Inclusion criteria: * Patients with hypertension and hypokalemia who have been diagnosed with primary aldosteronism following the latest version international guidelines for primary aldosteronism. * Age: 20-70 years old, male and female; * BMI: 18.5-23.9 kg/m2;

Exclusion criteria

* Other causes of endocrine hypertension including pheochromocytoma, Cushing syndrome, etc. * Renal artery stenosis and low potassium due to other factors, such as renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc. * History of hyperthyroidism, hepatic and renal insufficiency, malignant tumors, metabolic diseases, cardiovascular diseases, and mental diseases,menstrual disorders Healthy volunteers Inclusion criteria: * Age: 20-70 years old, male and female; * BMI: 18.5-23.9 kg/m2; * Blood pressure: 90-120/60-80 mmHg on three consecutive office blood pressure readings; * Female must have regular menstrual cycle (blood and urine samples should be taken during the non-menstrual period); * Regular dietary habits; * No medications taken within the past 1 month.

Design outcomes

Primary

MeasureTime frameDescription
Consistency of 2-day and 3-day 24h urinary aldosterone in the oral sodium load test4 dayTo explore whether there was statistical difference in the 24h urinary aldosterone on the 2nd day and the 3rd day detected by LC-MS (Liquid chromatography-tandem mass spectrometry) in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism

Secondary

MeasureTime frameDescription
Consistency of 2-day and 3-day PAC(Plasma aldosterone concentration) in the oral sodium load test4 dayTo explore whether there was statistical difference in plasma aldosterone concentration on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism.
Consistency of the plasma renin activity on the second day and the third day in oral sodium load test4 dayTo explore whether there was statistical difference in the plasma renin activity on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism
consistency of the the aldosterone-to-renin ratio(ARR) on the second day and the third day in oral sodium load test4 dayTo explore whether there was statistical difference in the aldosterone-to-renin ratio on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism

Countries

China

Contacts

Primary ContactTong Anli
tonganli@hotmail.com+8613460884085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026