Cohort Study of Adrenogenic Autonomic Cortisol Secretion

Not yet recruiting

• Conditions: Diagnosis; Adrenogenic Autonomic Cortisol Secretion; Treatment

• Registration Number: NCT05743933
• Lead Sponsor: Chongqing Medical University

Brief Summary

To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.

Detailed Description

With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. In our previous study, 18.9% of AI were accompanied by autonomic cortisol secretion (ACS) in Chinese. The vast majority of ACS is mild (MACS). Due to the lack of typical Cushing manifestations and the low rate of progression to overt Cushing, MACS has received insufficient attention in the past. However, recent studies have found that MACS have a higher incidence of diabetes, hypertension, cardiovascular events, metabolic bone disease and mortality risk than those with non-functional adenomas. With appropriate treatment, the complications of MACS patients can be effectively improved. However, personalized treatment of MACS is a clinical difficulty. It is hard to determine whether the cortisol secretion of patients is caused by AI or whether patients will benifit from operation. There are some retrospective studies have provided some evidence, while prospective studies are lacking. The purpose of this study is to prospectively include patients with autonomic cortisol secretion, evaluate function and diagnosis, develop personalized treatment strategy, and follow up the prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenogenic autonomic cortisol secretion in the future.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study Start: 2023-02-17
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Primary Completion: 2033-02-15
• Study Completion: 2033-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• CT examination revealed adrenal nodules (maximum diameter ≥10mm);
• Serum cortisol > 50nmol/L after 1mg dexamethasone inhibition test (1mg-DST).

Exclusion Criteria

• Patients with primary aldosteronism (PA), pheochromocytoma, adrenal metastatic carcinoma, congenital adrenal hyperplasia (CAH), ganglionic neuroma/paraganglioma, schwannoma, adrenal hematoma and those with no definite diagnosis were evaluated by clinical and endocrine function.
• Patients with serious underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamic-pituitary-adrenal axis (HPA axis); Pregnancy.
• Patients with a history of alcoholism, fatigue, trauma, infection, depression, glucocorticoid use, and other drugs affecting the function of the hypothalamic-pituitary-adrenal axis.
• Patients who are not willing to participate in and complete this study refuse to sign the written informed consent for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SUVmax value of PET-CT	10 years	To explore the value of 68\[Ga\]-Pentixafor PET-CT in the diagnosis of MACS

Secondary Outcome Measures

Name	Time	Method
Etiology and pathogenesis of adrenogenic autonomic cortisol secretion	10 years	To study the etiology and pathogenesis of adrenogenic autonomic cortisol secretion