UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010670 |
|---|---|
| Receipt number | R000012468 |
| Scientific Title | DIET-Valid Evaluation of carbohydrate affecting glucose fluctuation in type 2 diabetes |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2014/08/12 10:50:57 |
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Basic information
Public title
DIET-Valid Evaluation of carbohydrate affecting glucose fluctuation in type 2 diabetes
Acronym
D-VERDICT
Scientific Title
DIET-Valid Evaluation of carbohydrate affecting glucose fluctuation in type 2 diabetes
Scientific Title:Acronym
D-VERDICT
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the fluctuation of bloodglucose change durning low carbohydrate diet and usual guideline-recommended diet
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bloodglucose, IRI , FFA , urinary albumin,ketone body
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
3 days low carbohydrate diet
Interventions/Control_2
3 days usual diet for diabetes
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 DM
2) Equal to and more than 18 and less than 75years old
3) Do not have anti-dieabetic medicine nor insulin within 3 months
4) Latest HbA1c is 7.0-8.5% (NGSP)
5) 18<= BMI <=30
6) Serum creatinine is within normal range
7) Urine albumin <= 300mg/gCr
8) Capable of completing tha study
Key exclusion criteria
1) Secondary DM
2) Liver cirnhosis, history of surgery in intestinal tract or history of diesease influencing on the blood glucose
3) Not capable of completing tha study
4) Allergic to any food
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
The Jikei University School of Medicin
Division name
Department of Diabetes, Metabolism and Endocrinology
Zip code
Address
3-35-8,Nishi-Shinbashi,Minato-Ku,Tokyo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of Diabetes, Metabolism and Endocrinology
Zip code
Address
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
The Jikei University School of Medicine
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
| 2013 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2014 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012468
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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