UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049094 |
|---|---|
| Receipt number | R000055844 |
| Scientific Title | A study on changes in glycemic control in patients with type 2 diabetes using food delivery service |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2022/10/03 09:49:31 |
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Basic information
Public title
A study on changes in glycemic control in patients with type 2 diabetes using food delivery service
Acronym
A study on changes in glycemic control in patients with type 2 diabetes using food delivery service
Scientific Title
A study on changes in glycemic control in patients with type 2 diabetes using food delivery service
Scientific Title:Acronym
A study on changes in glycemic control in patients with type 2 diabetes using food delivery service
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the efficacy of ingesting energy controlled food delivery system five days a week on glycemic control in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c (%) before and after intervention
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Period: 5 meals per week x 4 weeks (total of 20 meals)
Quantity: Replace one meal for dinner with food delivery system
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with type 2 diabetes
2) Patients who are outpatients
3) Patients aged 20 to 80 at the time of informed consent
4) Patients who have given written informed consent to participate in this study
Key exclusion criteria
Patients who conflict with any of the following will not be included in this study.
1) Patients with severe renal dysfunction
2) Patients on hemodialysis
3) Patients diagnosed with cancer
4) Patients on protein restriction
5) Women who are pregnant or may become pregnant
6) Lactating women
7) Patients with severe food allergies who are considered to need restrictions on the menu
8) Other patients who are judged to be inappropriate by the Principal Investigator (co-investigator)
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Miyazaki |
Organization
Miyazaki RC Clinic
Division name
Respiratory Medicine
Zip code
140-0001
Address
Residence Shinagawa 3F, 2-23-2 Kitashinagawa, Shinagawa-ku, Tokyo
TEL
03-5460-1159
info@kita-shinagawa.clinic
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Miyazaki |
Organization
Miyazaki RC Clinic
Division name
Respiratory Medicine
Zip code
140-0001
Address
Residence Shinagawa 3F, 2-23-2 Kitashinagawa, Shinagawa-ku, Tokyo
TEL
03-5460-1159
Homepage URL
info@kita-shinagawa.clinic
Sponsor or person
Institute
Respiratory Medicine, Miyazaki RC Clinic
Institute
Department
Personal name
Funding Source
Organization
Sanmaruko Foods Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
2F, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2022 | Year | 10 | Month | 03 | 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
14
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
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055844
