UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046468 |
|---|---|
| Receipt number | R000053018 |
| Scientific Title | Investigational research of profiling on brain function in patients with obese type 1 diabetes using functional MRI. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/12/26 08:24:20 |
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Basic information
Public title
Investigational research of profiling on brain function in patients with obese type 1 diabetes using functional MRI.
Acronym
Profiling on brain function in patients with obese T1DM using functional MRI.
Scientific Title
Investigational research of profiling on brain function in patients with obese type 1 diabetes using functional MRI.
Scientific Title:Acronym
Profiling on brain function in patients with obese T1DM using functional MRI.
Region
| Japan |
Condition
Condition
Obesity, Type 1 diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to compare and profile brain function in patients with or without obese type 1 diabetes using task-related functional MRI.
Basic objectives2
Others
Basic objectives -Others
observation, compare
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the BOLD sign of the insular and amygdala, functional brain regions.
Key secondary outcomes
The morphological change in amygdala.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Obese and without obese patients with type 1 diabetes between the ages of 18 and 60 who are currently attending the University of the Ryukyus Hospital and affiliated hospital.
Key exclusion criteria
Patients who are assessed by the attending physician to be inappropriate for the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Chinen |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
Homepage URL
reda461@ryudai2nai.com
Sponsor or person
Institute
University of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
None
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
University of the Ryukyus.
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
Tel
098-895-1542
krinken@acs.u-ryukyu.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
| 2022 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 26 | Day |
Other
Other related information
The participants of this study were all patients who met the criteria and were seen at the University of the Ryukyus Hospital and related facilities during the period from the date of ethical review approval by the Ethics Committee of University of the Ryukyus for Medical and Health Research Involving Human Subjects to March 31, 2023. We will examine cross sectionally, and compare morphological change of amygdala which recognition and behavior , and profile BOLD change of brain in patients with or without obese type 1 diabetes using task-related functional MRI.
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053018
