UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057284 |
|---|---|
| Receipt number | R000065483 |
| Scientific Title | Long-term Follow-up Study of Severely Obese Patients with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/03/14 11:10:32 |
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Basic information
Public title
Long-term Follow-up Study of Severely Obese Patients with Type 2 Diabetes Mellitus
Acronym
Long-term Follow-up Study of Severely Obese Patients with T2DM
Scientific Title
Long-term Follow-up Study of Severely Obese Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym
Long-term Follow-up Study of Severely Obese Patients with T2DM
Region
| Japan |
Condition
Condition
Severe Obesity patient with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes in body weight in patients with type 2 diabetes mellitus complicated by severe obesity and investigate the factors contributing to significant weight loss.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in renal function, liver function, lipid profile, and HbA1c associated with body weight changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Renal function, lipid profile, liver function, and HbA1c
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with T2DM and severe obesity (BMI>=35)
Key exclusion criteria
Not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jinnouchi
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
Tel
0963630011
kurinami@jinnouchi.or.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
| 2025 | Year | 05 | Month | 31 | 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
37
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective long-term follow-up study on renal function in patients with type 2 diabetes mellitus and severe obesity, initially investigated in 2018. More than five years have passed, and this study aims to examine how baseline conditions and changes in treatment have influenced body weight fluctuations.
Management information
Registered date
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065483
