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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011864
Receipt No. 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

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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
Email 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
Email smorimoto@endm.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008208

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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