UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011864 |
|---|---|
| Receipt number | R000008208 |
| Scientific Title | Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/06/02 21:44:55 |
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Basic information
Public title
Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Acronym
Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Scientific Title
Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Scientific Title:Acronym
Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat mass and oxidative stress
Key secondary outcomes
1) HbA1c
2) high sensitive CRP
3) urinary protein/creatinine ratio, urinary albumin/creatinine ratio, eGFR
4) renin angiotensin system: plasma renin activity, plasma aldosterone concentration, plasma prorenin concentration, plasma soluble (pro) renin receptor, urinary prorenin excretion, urinary (pro)renin excretion
5) body weight, waist circumference, adiponectin
6) endothelial function: flow mediated dilation and nitroglycerin mediated dilation
7) atherosclerosis: CAVI and AI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with sitagliptin
Interventions/Control_2
treatment with acarbose
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 with diabetes mellitus
- HbA1c (JDS) of 6.1 to 8.0%
- under treatment with 1) diet therapy and exercise, 2) sulphonylurea, 3) metformin, or 4) suophnylurea and metformin
Key exclusion criteria
allergy to sitagliptin or acarbose
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Ichihara |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine II, Endocrinology and Hypertension
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
smorimoto@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Morimoto |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine II, Endocrinology and Hypertension
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
smorimoto@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学、東京都
Tokyo Women's Medical University, Tokyo
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008208
