Tokyo, March 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060807) titled 'Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery' on March 10.
Study Type:
Observational
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Severe obesity
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Measuring changes of adrenal hormone levels and CT volumetry of bilateral adrenal glands before and after metabolic surgery, and evaluate the relationships between these parameters and clinical otucomes.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - BMI over 35 kg/m2
18 to 65 years old
Resistant to medical therapy for more than six months
Diagnosed with more than one obesity-related disease
Key exclusion criteria - Secondary obesity (drug or endocrine disorders)
Severe mental illness (schizophrenia or poorly controlled depression)
Patients with alcohol dependence
Not obtain written informed consent
Target Size - 120
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 04 Month 01 Day
Date of IRB - 2026 Year 02 Month 20 Day
Anticipated trial start date - 2025 Year 04 Month 01 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069571
Disclaimer: Curated by HT Syndication.
