Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID06750172

Simplifying the Oral Sodium Loading Test for Diagnosing Primary Aldosteronism by Comparing 2-Day and 3-Day Urinary Aldosterone Measurements A Prospective Study Using Liquid Chromatography-tandem Mass Spectrometry

Led by Peking Union Medical College Hospital · Updated on 2024-12-27

33

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the consistency of 24-hour urinary aldosterone levels measured on the second and third days of an oral sodium loading test to diagnose primary aldosteronism. This exploratory, prospective study includes 17 healthy controls and 15 patients with primary aldosteronism. The goal is to determine if the aldosterone level on the second day can reliably replace the third day measurement for diagnosis, potentially simplifying the testing process. Participants follow a high-sodium diet for three consecutive days, with an additional 10 grams of salt per day. During this period, 24-hour urine samples are collected on both the second and third days to measure aldosterone, sodium, potassium, and creatinine levels. The study compares these measurements to assess the consistency between the two testing days. Throughout the study, participants undergo urine collections for laboratory analysis to monitor aldosterone and electrolyte levels. Researchers evaluate the primary outcome by measuring the consistency of 24-hour urinary aldosterone between the second and third days of the oral sodium load test. The total participation period involves the three-day dietary and urine collection phase, with close monitoring to ensure accurate data collection and safety.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hypertension and hypokalemia diagnosed with primary aldosteronism according to latest guidelines
  • Age between 20 and 70 years, male and female
  • Body mass index between 18.5 and 23.9 kg/m2
  • For healthy volunteers: blood pressure 90-120/60-80 mmHg on three consecutive office readings
  • For healthy female volunteers: regular menstrual cycle and blood/urine samples taken during non-menstrual period
  • Regular dietary habits
  • No medications taken within the past month
Not Eligible

You will not qualify if you...

  • Endocrine hypertension causes other than primary aldosteronism, such as pheochromocytoma or Cushing syndrome
  • Renal artery stenosis or low potassium due to renal tubular acidosis, Bartter syndrome, Gitelman syndrome, or other factors
  • History of hyperthyroidism, liver or kidney insufficiency, malignant tumors, metabolic diseases, cardiovascular or mental disorders, menstrual disorders
  • For healthy volunteers: history of hypokalemia, liver or kidney dysfunction, malignant tumors, metabolic or cardiovascular diseases, psychiatric disorders
  • Menstrual irregularities or use of contraceptive pills
  • History of hypertension
  • Use of anti-inflammatory drugs, potassium diuretics, or special health products within 4 weeks prior to examination

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100010

Actively Recruiting

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Research Team

T

Tong Anli

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Surprisingly low aldosterone levels in peripheral veins following intravenous sedation during adrenal vein sampling: implications for the concept of nonsuppressibility in primary aldosteronism.

Gregory A Kline, Pol Darras, Alexander A Leung...

https://pubmed.ncbi.nlm.nih.gov/30703073

The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.

John W Funder, Robert M Carey, Franco Mantero...

https://pubmed.ncbi.nlm.nih.gov/26934393