UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015560 |
|---|---|
| Receipt number | R000018080 |
| Scientific Title | Clinical investigation and analysis for metabolism improving effects of highly functional rice "AMIROMOCHI" |
| Date of disclosure of the study information | 2014/10/30 |
| Last modified on | 2014/10/29 19:30:52 |
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Basic information
Public title
Clinical investigation and analysis for metabolism improving effects of highly functional rice "AMIROMOCHI"
Acronym
Clinical investigation about improvement of metabolism by highly functional rice
Scientific Title
Clinical investigation and analysis for metabolism improving effects of highly functional rice "AMIROMOCHI"
Scientific Title:Acronym
Clinical investigation about improvement of metabolism by highly functional rice
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of highly functional rice "AMIROMOCHI" on metabolic parameters and vascular function in patients who have type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body measurement(body weight, abdominal girth), blood pressure, plasma levels of glucose, insulin, lipids and vascular endothelial function before and after 2-weeks ingestion of highly functional rice "AMIROMOCHI" and control wild-type rice
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
2 weeks ingestion of highly functional rice "AMIROMOCHI"
Interventions/Control_2
2 weeks ingestion of control wild-type rice
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
Subjects who have type2 diabetes mellitus
Key exclusion criteria
1)Subjects who became severe ketosis, diabetic coma or the previous coma within the past six months
2)Subjects who have infectious diseases or history of recent operation and injury
3)Expected, pregnant or lactating women
4)Subjects who have severe renal dysfunction (male: sCr>1.5mg/dL, female: sCr>1.3mg/dL)
5)Subjects who have cardiac arrest (class of III or IV in NYHA)
6)Inadequately controlled high blood pressure (Systolic arterial pressure >160mmhg diastolic pressure >100mmhg)
7)Subjects who have liver dysfunction (AST or ALT>100IU/L)
8)Subjects who have history of malignant tumor (possible entry: no recrudescence of tumor more than 10 years)
9)Subjects to be inappropriate as an object of this examination by other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Masuzaki, MD, phD |
Organization
Faculty of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa, 903-0215, Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Nakamura, MD |
Organization
Faculty of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL
098-895-1146
Homepage URL
ryudai2ndint_2008_1979@yahoo.co.jp
Sponsor or person
Institute
Faculty of Medicine, University of the Ryukyus, Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Okinawa prefecture
Organization
Division
Category of Funding Organization
Local Government
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
| 2014 | Year | 10 | Month | 30 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2014 | Year | 10 | Month | 29 | Day |
Last modified on
| 2014 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018080
