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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010670
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Jikei University School of Medicine
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012468

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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