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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Primary Aldosteronism

Treatments: Diagnostic Test: The oral sodium loading test

Study type: Observational

Funder types: Other

Identifiers

NCT06750172

pumch-06086-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria:

• History of hypokalemia.
• History of liver and kidney dysfunction, malignant tumors, metabolic disorders, cardiovascular diseases, and psychiatric disorders, etc.
• Menstrual irregularities and taking contraceptive pills.
• History of hypertension
• Have taken any drugs including anti-inflammatory drugs, potassium diuretics, or special health products in the 4 weeks prior to the examination,

Trial design

33 participants in 2 patient groups

Primary aldosteronism(PA)

Description:

Inclusion criteria: Patients with hypertension and hypokalemia who have been diagnosed with primary aldosteronism following the latest version international guidelines for primary aldosteronism. 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 * Special drugs such as glucocorticoids, immunosuppressants, and oral contraceptives should * Diabetes mellitus with HbA1c\>7.0% or with insulin or SGLT2 inhibitors were also excluded.

Treatment:

Diagnostic Test: The oral sodium loading test

healthy control

Description:

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. Exclusion criteria: History of hypokalemia. History of liver and kidney dysfunction, malignant tumors, metabolic disorders, cardiovascular diseases, and psychiatric disorders, etc. Menstrual irregularities and taking contraceptive pills. * History of hypertension * Have taken any drugs including anti-inflammatory drugs, potassium diuretics, or special health products in the 4 weeks prior to the examination,

Treatment:

Diagnostic Test: The oral sodium loading test