UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044969 |
|---|---|
| Receipt number | R000051377 |
| Scientific Title | Randomized prospective study to investigate the association between intestinal FDG accumulation on 18F-FDG-PET/MRI and various parameters in patients taking metformin or vildagliptin |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/27 14:04:36 |
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Basic information
Public title
Randomized prospective study to investigate the association between intestinal FDG accumulation obtained using 18F-FDG-PET/MRI and various parameters in patients taking metformin or vildagliptin
Acronym
A prospective study to investigate the relationship between intestinal FDG accumulation obtained by PET/MRI and various parameters in patients taking metformin or vildagliptin
Scientific Title
Randomized prospective study to investigate the association between intestinal FDG accumulation on 18F-FDG-PET/MRI and various parameters in patients taking metformin or vildagliptin
Scientific Title:Acronym
Study to investigate the association between intestinal FDG accumulation on PET/MRI and various parameters in patients taking metformin or vildagliptin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the dynamics of glucose derivatives (FDG) by 18F-FDG-PET/MRI and the association and changes with the intestinal flora by oral administration of metformin and vildagliptin for a certain period of time
Basic objectives2
Others
Basic objectives -Others
Comparison between groups of changes in gut microbiota and metabolism-related products before and after treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of semi-quantitative evaluation (SUVmean) of FDG accumulation at each site of the intestinal tract in the metformin group and vildagliptin group analyzed using 18F-FDG-PET/MRI 12 weeks after the start of treatment
Key secondary outcomes
Changes in glycemic control, weight, and abdominal circumference before and after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After taking metformin or vildagliptin for 12 weeks, PET/MRI is taken
Interventions/Control_2
Blood tests are performed monthly and feces are collected before and after treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Type 2 diabetes
2.20-75 years old
3.Patients who are judged by the attending physician to be required to receive metformin or vildagliptin
4.Patients who showed an understanding of the medication method in this study
5.Patients who have obtained written consent from the person
6.Patients who have only diet/exercise therapy for diabetes treatment within the last month
Key exclusion criteria
1.Patients who are pregnant or breastfeeding and may become pregnant
2.Patients with a history of skin lesions with oral hypoglycemic agents or insulin
3.Patients with type 1 diabetes, including slowly progressive type, or other types of diabetes
4.Severe liver dysfunction
5.Severe renal dysfunction
6.Patients with severe cardiac dysfunction
7.Users of alpha glucosidase inhibitors, DPP4 inhibitors, SGLT2 inhibitors, and GLP1 receptor agonists within 1 month
8.Patients who have used antibiotics or antiparasitics within 1 month
9.Patients who used laxatives within 1 month
10.Patients who took PPI, corticosteroids, and immunosuppressive drugs within 1 month
11.Gastrointestinal diseases
12.Patients who have had gastrointestinal surgery in the past
13.Patients with new or recurrent malignancies within 1 year
14.Patients who are judged by the attending physician to have a mental illness
15.Patients who have internal implants
16.Others who are judged by researchers to be unsuitable for this research
17.Patients who are judged by the attending physician to be in acute metabolic ataxia
18.Patients who are judged to be unsuitable for taking the study drug
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
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
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Tel
0783826669
kainyu@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051377
