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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043719
Receipt No. R000049817
Scientific Title Association between the efficacy of DPP-4 inhibitors and eating behavior/taste index
Date of disclosure of the study information 2021/03/25
Last modified on 2021/03/23

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Basic information
Public title Association between the efficacy of DPP-4 inhibitors and eating behavior/taste index
Acronym Association between the efficacy of DPP-4 inhibitors and eating behavior/taste index
Scientific Title Association between the efficacy of DPP-4 inhibitors and eating behavior/taste index
Scientific Title:Acronym Association between the efficacy of DPP-4 inhibitors and eating behavior/taste index
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assess eating behavior, and the taste threshold in patients with Diabetes before and after treatment with a DPP-4 inhibitor to clarify the association between the effects of this drug and the eating behavior/taste index.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of DPP-4 inhibitors and indices for food intake such as eating behavior or taste threshold
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DPP-4 inhibitors 4w
Interventions/Control_2 therapy not
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
25 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria patientin which therapy with a DPP-4 inhibitor was started during the study
Key exclusion criteria When the person in charge of research determines that participation in this research is inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chieko
Middle name
Last name Sakai
Organization School of Health Sciences, Faculty of Medicine, Tottori University
Division name Department of Adult and Eldery Nursing
Zip code 683-8503
Address 86 Nishi-cho, Yonago 683-8503, Japan
TEL 0859-38-6317
Email sakai@tottori-u.ac.jp

Public contact
Name of contact person
1st name Chieko
Middle name
Last name Sakai
Organization School of Health Sciences, Faculty of Medicine, Tottori University
Division name Department of Adult and Eldery Nursing
Zip code 683-8503
Address 86 Nishi-cho, Yonago 683-8503, Japan
TEL 0859-38-6317
Homepage URL
Email sakai@tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Tottori University
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 School of Health Sciences, Faculty of Medicine, Tottori University
Address 86 Nishi-cho, Yonago 683-8503, Japan
Tel 0859-38-6317
Email sakai@tottori-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 03 Month 25 Day

Related information
URL releasing protocol Unpublished
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 37
Results We compared eating behavior before and after treatment. In both the treatment and control groups, the high-fat diet/fast food preference scores decreased after treatment. However, there was no difference between the two groups. When comparing the taste threshold before and after treatment, the sweet taste thresholds in the two groups reduced after treatment, although there was no difference between the two groups.
Results date posted
2021 Year 03 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics treatment group, n=20
control group, n=17
Participant flow treatment group, n=20
control group, n=17
Adverse events NO
Outcome measures 1)Evaluation of Eating Behaviors
2)Evaluation of Taste Thresholds
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 09 Month 15 Day
Date of IRB
2011 Year 08 Month 31 Day
Anticipated trial start date
2011 Year 09 Month 30 Day
Last follow-up date
2012 Year 03 Month 15 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 03 Month 23 Day
Last modified on
2021 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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