UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016484
Receipt number 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 11:34:45

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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 or person

Institute

Department of Biostatistics and Epidemiology,
Yokohama City University Medical Center

Institute

Department

Personal name



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

Value
https://center6.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