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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
