UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043719 |
|---|---|
| Receipt number | 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 16:30:06 |
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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
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
sakai@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049817
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
