UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012167 |
|---|---|
| Receipt number | R000014224 |
| Scientific Title | Effects of beta-cryptoxanthin on glucose metabolism (Acute phase) |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2013/10/30 13:35:11 |
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Basic information
Public title
Effects of beta-cryptoxanthin on glucose metabolism (Acute phase)
Acronym
Acute effect of beta-cryptoxanthin
Scientific Title
Effects of beta-cryptoxanthin on glucose metabolism (Acute phase)
Scientific Title:Acronym
Acute effect of beta-cryptoxanthin
Region
| Japan |
Condition
Condition
IGT
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study was to evaluate the glucose metabolism of beta-cryptoxanthin containing beverages versus placebo in patients with IGT and type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose fluctuation
M values, MAGE, and blood glucose standard deviation were calculated from CGM
Key secondary outcomes
1.Changes in the physical findings(Body weight/waist circumference/Blood pressure/
Heart rate/The body composition by impedance method)
2.Evaluation of verification and safety of adverse events (hypoglycemia, hyperglycemia, gastrointestinal symptoms)
3.Factors associated with effect of glucose metabolism
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
beta-cryptoxanthin containing beverages
Interventions/Control_2
placebo
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
1.Impaired glucose tolerance patients and patients with type 2 diabetes
2.purpose education hospitalization
3.Patient capable of glycemic control
4.FPG <400mg/dl on admission and
FPG <150 mg / dl at the start of the test
Key exclusion criteria
1.history of type 1 diabetes or history of ketoacidosis
2.history of hypoglycemia severe symptoms associated with loss of consciousness or coma
3.severe infection, the severe trauma
4. poorly controlled hypertension, systolic blood pressure >160 mmHg, or diastolic blood pressure >100
5.patients with grade 3 or more of the Ministry of Health, Labour and Welfare drug side effects classification serious complication
6.pregnancy or breast feeding
7.inability to participate in the study as assessed by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuguhito Ota |
Organization
Kanazawa University
Division name
Brain/Liver Interface Medicine Research Center
Zip code
Address
13-1 Takara-machi Kanazawa, Japan
TEL
076-265-2863
tota@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuguhito Ota |
Organization
Kanazawa University Hospital
Division name
Department of Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa, Japan
TEL
076-265-2234
Homepage URL
tota@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Brain/Liver Interface Medicine Research Center, Japan
Institute
Department
Personal name
Funding Source
Organization
National Agruculture and Food Research Organization
Organization
Division
Category of Funding Organization
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
| 2013 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 10 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014224
