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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016484
Receipt No. R000019099
Scientific Title Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Date of disclosure of the study information 2015/02/16
Last modified on 2015/02/09

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Basic information
Public title Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Acronym Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Scientific Title Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Scientific Title:Acronym Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was conducted to verify the effect of carbohydrate intake ratio(50% or 60%) on the QOL of Patients with type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others Japan Diabetes Society suggested that the carbohydrate intake ratio of patients with type 2 diabetes must be 50-60% in their recommendation in March 2013. Furthermore general practitioner should consider of the safety of diet therapy, food culture of Japan, ndividual taste for food and QOL. There are few Intervention study in carbohydrate intake ratio in Japan. We think that verification of the effect of carbohydrate intake ratio on the QOL of Patients with type 2 diabetes is very important and have high clinical value.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes QOL(DTR-QOL) (at the time of entry, and at 6 and 12 month after)
Key secondary outcomes 1) HbA1c, Fasting plasma glucose
2) Serum Lipid(TC,TG,HDL-C,LDL-C)
3) urine albumin
4) Body Weight, Body Mass Index
5) Problem Areas in Diabetes Survey(PAID)
6) Brief-type Self -administered Diet History Questionnaire(BDHQ)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 carbohydrate intake ratio 50%
Interventions/Control_2 carbohydrate intake ratio 60%
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient with type2 diabetes who has not received nutrition education for diabetes within the past 6 months.
2) HbA1c 8.0%<= and 14%>
Key exclusion criteria 1) Patient suffer from diabetic ketosis, diabetic coma within the past 6 months.
2) Patient with severe infection, severe injury, before and after operation.
3) Patient with over diabetic nephropathy stage 3, and aCKD stage3.
4) Serum creatinine 1.5mg/dl<= within past 2 month.
5) Patient with severe liver dysfunction.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Yamakawa
Organization Yokohama City University Medical Center
Division name Department of endocrinology & metabolism
Zip code
Address 4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL 045-261-5656
Email yamakat@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Takahashi
Organization Yokohama City University Medical Center
Division name Department of endocrinology & metabolism
Zip code
Address 4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email ken5073@yokohama-cu.ac.jp

Sponsor
Institute Department of Biostatistics and Epidemiology,
Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 16 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 Preinitiation
Date of protocol fixation
2015 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2015 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019099

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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