UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060807 |
|---|---|
| Receipt number | R000069571 |
| Scientific Title | Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/03 05:15:06 |
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Basic information
Public title
Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery
Acronym
Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery
Scientific Title
Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery
Scientific Title:Acronym
Relationships between adrenal volume, hormonal status and metabolic improvement in patients with severe obesity undergoing metabolic surgery
Region
| Japan |
Condition
Condition
Severe obesity
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Postoperative changes of adrenal hormones
2 Changes of adrenal volume
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | Medical |
| Last name | Umemura |
Organization
School of Medicine,Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
0196137111
auau001@hotmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | Medical |
| Last name | Umemura |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
0196137111
Homepage URL
aumemura@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical Univerisity
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
Tel
0196137111
aumemura@iwate-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adrenal hormones
Adrenal volume
Weight-loss effect
Metabolic improvement
Management information
Registered date
| 2026 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069571
