UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055445 |
|---|---|
| Receipt number | R000063354 |
| Scientific Title | Study to determine the relationship between intestinal FDG accumulation and obesity in non-diabetic patients |
| Date of disclosure of the study information | 2024/09/06 |
| Last modified on | 2024/09/06 15:39:05 |
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Basic information
Public title
Study to determine the relationship between intestinal FDG accumulation and obesity in non-diabetic patients
Acronym
the relationship between intestinal FDG accumulation and obesity
Scientific Title
Study to determine the relationship between intestinal FDG accumulation and obesity in non-diabetic patients
Scientific Title:Acronym
Study to determine the relationship between intestinal FDG accumulation and obesity
Region
| Japan |
Condition
Condition
non-diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of FDG accumulation between two groups of non-diabetic patients: normal weight group and obese group with BMI over 30
Basic objectives2
Others
Basic objectives -Others
Comparison of background factors between normal weight group and obese group
Correlation between the visual evaluation of intestinal FDG accumulation and patients' background factors
Semi-quantitative evaluation of intestinal FDG accumulation in non-diabetic patients and comparison of FDG accumulation between normal weight group and obese group
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation of FDG accumulation
Key secondary outcomes
Comparison of patient background factors between the two groups
Correlation between visual assessment of intestinal FDG accumulation and patient background factors
Semi-quantitative evaluation of intestinal FDG accumulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent 18F FDG PET MRI examination and whose details can be obtained from their medical records
Patients who are 20 years of age or older
Patients who have not been diagnosed as diabetic based on the information in the medical record
Patients who are not receiving oral or injectable diabetes medication based on the information in the medical record
Non diabetic patients whose body mass index (BMI) is between 18.5 and 25 (normal weight group)
Non diabetic patients with body mass index (BMI) of 30 or more (obese group with body mass index of 2 or more)
Key exclusion criteria
(i) If 18F-FDG-PET/MRI examination has been performed multiple times, for the first imaging and for the third and subsequent imaging
(ii) Those who have a record of HbA1c of 6.5% or higher from the medical record
(iii) Patients with end-stage renal failure with eGFR less than 30 mL/min/1.73m2 from the medical record
(iv) Patients whose intestine to be analyzed has been resected
(v) Patients with incidental intestinal cancer other than the main disease in the intestinal tract to be analyzed
(vi) Patients for whom 18FDG-PET/MRI images are judged to be inappropriate.
(vii) Patients who have requested not to participate in this study based on the disclosed information.
(viii) Patients whom the principal investigator determines to be inappropriate for this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe University Hospital
Division name
Department of General Internal Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Morita |
Organization
Kobe University Hospital
Division name
Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Ethics committee of Kobe university
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5861
kzhkskgc@med.kobe-u.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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 06 | 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
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After Initiation
Management information
Registered date
| 2024 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063354
