UMIN-CTR Clinical Trial

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
Email	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
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051377