UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical assessment of long-term glucose-lowering effects of DPP-4 inhibitor under different dietary habits in Japanese individual with type 2 diabetes
Title of the study (Brief title)	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	Daisuke Yabe
Organization	Kansai Electric Power Medical Research Institute
Division name	Yutaka Seino Distinguished Center for Diabetes Center
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	Daisuke Yabe
Organization	Kansai Electric Power Medical Research Institute
Division name	Yutaka Seino Distinguished Center for Diabetes Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031942