UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017632 |
|---|---|
| Receipt number | 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 12:02:13 |
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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
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
kazu.kamiko@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020420
