UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006524 |
|---|---|
| Receipt number | 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 09:15:11 |
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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
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
ysaisho@z5.keio.jp
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism
Department of Internal Medicine
Keio 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007735
