Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method
NCT ID: NCT06750172
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
33 participants
OBSERVATIONAL
2023-12-15
2024-12-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary aldosteronism(PA)
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.
The oral sodium loading test
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
healthy control
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 â–ªtaken 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,
The oral sodium loading test
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
Interventions
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The oral sodium loading test
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
Eligibility Criteria
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Inclusion Criteria
* Age: 20-70 years old, male and female;
* BMI: 18.5-23.9 kg/m2;
* 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
* 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
* 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,
18 Years
70 Years
ALL
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Tong Anli
Role: primary
References
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Turcu AF, Yang J, Vaidya A. Primary aldosteronism - a multidimensional syndrome. Nat Rev Endocrinol. 2022 Nov;18(11):665-682. doi: 10.1038/s41574-022-00730-2. Epub 2022 Aug 31.
Funder JW. Sensitivity to aldosterone: plasma levels are not the full story. Hypertension. 2014 Jun;63(6):1168-70. doi: 10.1161/HYPERTENSIONAHA.114.03127. Epub 2014 Apr 7. No abstract available.
Kline GA, Darras P, Leung AA, So B, Chin A, Holmes DT. Surprisingly low aldosterone levels in peripheral veins following intravenous sedation during adrenal vein sampling: implications for the concept of nonsuppressibility in primary aldosteronism. J Hypertens. 2019 Mar;37(3):596-602. doi: 10.1097/HJH.0000000000001905.
Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.
Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
Other Identifiers
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pumch-06086-08
Identifier Type: -
Identifier Source: org_study_id