UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000351
Receipt number R000000450
Scientific Title The effect of the carbohydrate-reduced diet(CARD) on outpatients with type 2 diabetes
Date of disclosure of the study information 2006/04/01
Last modified on 2006/09/27 19:01:27

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Basic information

Public title

The effect of the carbohydrate-reduced diet(CARD) on outpatients with type 2 diabetes

Acronym

E-CARD

Scientific Title

The effect of the carbohydrate-reduced diet(CARD) on outpatients with type 2 diabetes

Scientific Title:Acronym

E-CARD

Region

Japan


Condition

Condition

typy 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of the carbohydtate-redeced diet (CARD) on a glycemic control and safety in type 2 diabetic outpatients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c level, BMI, dose of sulfonylurea

Key secondary outcomes

concentrations of serum lipids, creatinine and uric acid


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

carbohydrate-reduced deit

Interventions/Control_2

conventional diabetic diet

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

Type 2 diabetic outpatients with HbA1c 6.5% and above

Key exclusion criteria

Patients with a serum creatinine level>2.0mg/dl, diabetic neuropathy with symptoms, proliferative diabetic retnopathy and malignant tumors

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Haimoto

Organization

Haimoto Clinic

Division name

Clinical Division

Zip code


Address

1-80 Yayoicho, Kasugai, Aichi 486-0838, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hajime Haimoto

Organization

Haimoto Clinic

Division name

Clinical Division

Zip code


Address

1-80 Yayoicho, Kasugai, Aichi 486-0838, Japan

TEL

0568-85-0567

Homepage URL


Email

haimoto@gol.com


Sponsor or person

Institute

Haimoto Clinic

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



Other administrative information

Date of disclosure of the study information

2006 Year 04 Month 01 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

No longer recruiting

Date of protocol fixation

2003 Year 01 Month 31 Day

Date of IRB


Anticipated trial start date

2003 Year 04 Month 01 Day

Last follow-up date

2006 Year 03 Month 01 Day

Date of closure to data entry

2006 Year 11 Month 01 Day

Date trial data considered complete

2007 Year 02 Month 01 Day

Date analysis concluded

2007 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 03 Month 08 Day

Last modified on

2006 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name