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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027876
Receipt No. R000031942
Scientific Title Clinical assessment of long-term glucose-lowering effects of DPP-4 inhibitor under different dietary habits in Japanese individual with type 2 diabetes
Date of disclosure of the study information 2017/06/22
Last modified on 2017/06/22

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Basic information
Public title Clinical assessment of long-term glucose-lowering effects of DPP-4 inhibitor under different dietary habits in Japanese individual with type 2 diabetes
Acronym DPP-4i and dietary habits
Scientific Title Clinical assessment of long-term glucose-lowering effects of DPP-4 inhibitor under different dietary habits in Japanese individual with type 2 diabetes
Scientific Title:Acronym DPP-4i and dietary habits
Region
Japan

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

Objectives
Narrative objectives1 To assess potential relationship between dietary contents, especially intakes of macro-nutrients and fats, and the long-term durability of DPP-4 inhibitor sitagliptin in Japanese individuals with type 2 diabetes
Basic objectives2 Others
Basic objectives -Others To assess potential relationship between body-weight changes and the long-term durability of DPP-4 inhibitor sitagliptin in Japanese individuals with type 2 diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in intake of carbohydrates, proteins and fats as well as that of saturated fats, monounsaturated fats, and polyunsaturated fats between patients with HbA1c deteriorated 6 months after sitagliptin initiation [deltaHbA1c (12-6 mo) 0.4% or less] and those with HbA1c maintained [deotaHbA1c(12-6mo) above 0.4%]
Key secondary outcomes Differences in bodyweight cahnges between patients with HbA1c deteriorated 6 months after sitagliptin initiation [deltaHbA1c (12-6 mo) 0.4% or less] and those with HbA1c maintained [deotaHbA1c(12-6mo) above 0.4%]

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Those initiated and continued DPP-4 inhibitor sitagliptin monotherapy for 12 months
2) those submitted at least one 3-day food record during 18 months after sitagliptin initiation
3) those received at least four measurements of HbA1c, creatinine and bodyweight during 12 months after sitagliptin initiation
Key exclusion criteria 1) Those initiated sitagliptin monotherapy in replacement of other anti-diabetic
2) Those received other anti-diabetic drugs during 0 - +12 months after sitagliptin initiation
3) Those received medications affecting HbA1c levels during 0 - +12 months after sitagliptin initiation
4) those had moderate/severe renal insufficiency (creatinine >1.5 mg/dL) at sitagliptin initiation
5) those had moderate/severe hepatic insufficiency (Child-Pugh B or above) at sitagliptin initiation
6) Those became pregnant during 0 - +12 months after sitagliptin initiation
7) Those received anti-cancer therapies during -12 - +24 months after sitagliptin initiation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Yabe
Organization Kansai Electric Power Medical Research Institute
Division name Yutaka Seino Distinguished Center for Diabetes Center
Zip code
Address 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-303-6090
Email ydaisuke-kyoto@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Yabe
Organization Kansai Electric Power Medical Research Institute
Division name Yutaka Seino Distinguished Center for Diabetes Center
Zip code
Address 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-303-6090
Homepage URL
Email ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute Kansai Electric Power Medical Research Institute
Institute
Department

Funding Source
Organization Kansai Electric Power Medical Research Institute
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 22 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 Completed
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 22 Day
Last modified on
2017 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031942

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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