UMIN-CTR Clinical Trial

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
Email	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
Email	info@kita-shinagawa.clinic

Sponsor
Institute	Respiratory Medicine, Miyazaki RC Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055844