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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000351
Receipt No. 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

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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
Institute Haimoto Clinic
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

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
URL(English) https://upload.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


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