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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017632
Receipt No. R000020420
Scientific Title Effect of ingestion speed of the high density liquid diet on glucose metabolism and gastrointestinal hormone in patients with type 2 diabetes and healthy men
Date of disclosure of the study information 2015/05/21
Last modified on 2016/11/28

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Basic information
Public title Effect of ingestion speed of the high density liquid diet on glucose metabolism and gastrointestinal hormone in patients with type 2 diabetes and healthy men
Acronym Effect of ingestion speed of liquid diet on glucose metabolism
Scientific Title Effect of ingestion speed of the high density liquid diet on glucose metabolism and gastrointestinal hormone in patients with type 2 diabetes and healthy men
Scientific Title:Acronym Effect of ingestion speed of liquid diet on glucose metabolism
Region
Japan

Condition
Condition Patients with type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of meal intake speed on glucose metabolism and gastric intstinal hormone
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma glucose levels at 0, 30, 60 and 120 min after taking liquid diet
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Liquid diet(Fast speed)
Interventions/Control_2 Liquid diet(Slow speed)
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 Patients with type 2 diabetes and men with normal glucose tolerance
Key exclusion criteria Patients who are taking oral hypoglycemic agents except sulphonylurea or metformin
Patients with insulin injection
Patinets with malignacy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aoki
Organization Yokohama City University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL 045-787-2800
Email aokikazu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Kamiko
Organization Yokohama city University
Division name Department of Endocrinology and Metabolism
Zip code
Address Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL 045-787-2511
Homepage URL
Email kazu.kamiko@gmail.com

Sponsor
Institute Yokohama City University Hospital
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
2015 Year 05 Month 21 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
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 21 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
2015 Year 05 Month 20 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020420

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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