Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism

NCT06534268 | Not Yet Recruiting DMC

• 1 other identifier: RJ-PA-NEW-1
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (10)

• The gender and age of the participants

  age in years and sex (female or male) of patients

  1 day

• Participant's weight and height

  BMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2

  1 day

• Patients' baseline hormone level

  serum hormone level

  1day

• Number of Participants with baseline glucose metabolic levels

  glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc

  1 day

• Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test

  cortisol and aldosterone levels

  1day

• Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test

  cortisol and aldosterone levels

  1day

• Number of Participants with baseline lipid metabolic levels

  blood lipid levels

  1day

• Patients' baseline glucose metabolic levels

  0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT

  1day

• Number of Participants with baseline electrolytes levels

  sodium, potassium, chloride, calcium, and phosphorus ion levels

  1day

• Number of Participants with baseline kidney function levels

  Creatinine, blood urea nitrogen (BUN), and uric acid levels

  1day

Secondary Outcomes (4)

• the changes of hormone levels after surgical management

  1day

• Number of Participants with changes of lipid metabolic levels after surgical management

  1day

• the changes of glucose metabolic levels after surgical management

  1day

• Number of Participants with changes of kidney function levels after surgical management

  1 day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study intends to include 200 patients diagnosed with primary aldosteronism undergoing surgery. An ACTH stimulation test will be performed within one week postoperatively. The participants will be aged 18-75 years, with no gender restrictions. Exclusion criteria include patients using medications that affect adrenal cortical function, patients with a history of adrenal surgery, pregnant or breastfeeding women, and patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function

You may qualify if:

• Patients diagnosed with unilateral primary aldosteronism who undergo surgical treatment and have their cortical function assessed by an ACTH stimulation test within one week postoperatively.

You may not qualify if:

• Patients using medications that affect adrenal cortical function.
• Patients with a history of adrenal surgery
• Pregnant or breastfeeding women
• Patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function

Sponsors & Collaborators

• Ruijin Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

patient serum

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 2, 2024
• Study Start: August 15, 2024
• Primary Completion: March 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share