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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006524
Receipt No. R000007735
Scientific Title Efficacy of intermittent food delivery service on diet therapy for type 2 diabetes
Date of disclosure of the study information 2011/11/01
Last modified on 2015/10/11

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Basic information
Public title Efficacy of intermittent food delivery service on diet therapy for type 2 diabetes
Acronym Efficacy of intermittent food delivery service on diet therapy for type 2 diabetes
Scientific Title Efficacy of intermittent food delivery service on diet therapy for type 2 diabetes
Scientific Title:Acronym Efficacy of intermittent food delivery service on diet therapy for type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of food delivery service on diet therapy for type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes * Change in DTSQ score
* Questionaire of food delivery service
* Change in diet pattern
* Change in metabolic parameters
* Change in body weight
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients who participated to this study choose one of two following options;
1) intermittent delivery (delivery at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 months)
2) continuous delivery (delivery consecutive first 9 days)
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients age over 20 years old who agree with study participation
Key exclusion criteria 1. patients with severe renal dysfunction (serum creatinine 2.5mg/dl or more) or on hemodialysis
2. patients with malignancy
3. pregnant women
4. patients who are disqualified from the study by investigator for any reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Saisho
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi Shinjukuku Tokyo
TEL 0353633797
Email ysaisho@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Saisho
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi Shinjukuku Tokyo
TEL 0353633797
Homepage URL
Email ysaisho@z5.keio.jp

Sponsor
Institute Division of Nephrology, Endocrinology and Metabolism
Department of Internal Medicine
Keio 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
2011 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 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
2011 Year 10 Month 11 Day
Last modified on
2015 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007735

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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