UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027876
Receipt number 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 20:35:33

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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 or person

Institute

Kansai Electric Power Medical Research Institute

Institute

Department

Personal name



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

Value
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