Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Tong Anli
- 電話番号:+8613460884085
- メール:tonganli@hotmail.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100000
- 募集
- Peking Union Medical Colledge Hospital
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コンタクト:
- Li Zewen
- メール:b2023001041@pumc.edu.cn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion criteria for the normal control group: Age 18-70 years old, BMI: 18.5-23.9kg/m ²,gender not restricted. blood pressure: 100-120/60-80mmHg. no history of hypertension. No abnormal nodules found in adrenal CT. Previous blood potassium and electrocardiogram were all within normal ranges., No history of liver or kidney dysfunction, malignant tumors, metabolic diseases or cardiovascular diseases, and no medication used.
Exclusion criteria: Those with a family history of hypertension or with clinical manifestations of secondary hypertension. Those who have been taking drugs that may affect the RAAS system for a long time (such as contraceptives, steroids, etc.). Those with cardiac dysfunction or severe arrhythmia and unable to tolerate the test.
Patients with suspected primary aldosteronism in the outpatient setting. Inclusion criteria: Patients with suspected primary aldosteronism in the outpatient setting. Willing to undergo 4-week spironolactone treatment and cooperate with follow-up.
Exclusion criteria: Patients who did not complete the oral sodium loading test. Patients with Cushing's syndrome or other endocrine tumors. Patients allergic to spironolactone or with contraindications for its use (such as severe hyperkalemia, eGFR < 30).History of liver or kidney dysfunction, coexisting severe cardiovascular or cerebrovascular diseases, history of malignant tumors, other types of endocrine hypertension (hyperthyroidism, pheochromocytoma, Cushing's syndrome, etc.), renal artery stenosis, hypokalemia caused by other factors (renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.), diabetes with HbA1c > 7.0% or currently using or having used insulin or SGLT2 inhibitor drugs, taking special medications such as glucocorticoids, immunosuppressants, oral contraceptives, etc.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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normal sujects
Healthy volunteers with normal blood pressure and blood potassium levels and no adrenal nodules.
These volunteers were used to determine the normal physiological range (lower limit value) of aldosterone inhibition after the test.
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These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day.
On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.
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Patients suspected of having primary aldosteronism
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These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day.
On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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24-hour urinary aldosterone levels after a 3-day high-sodium diet
時間枠:Two weeks after completing the oral sodium loading test
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Two weeks after completing the oral sodium loading test
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- pumch-06086-10
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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