UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012166 |
|---|---|
| Receipt number | R000014225 |
| Scientific Title | Effect of beta-cryptoxanthin on the glucose metabolism in diabetic patients (chronic phase) |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2013/10/30 13:51:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of beta-cryptoxanthin on the glucose metabolism in diabetic patients (chronic phase)
Acronym
Chronic effect of beta-cryptoxanthin on the glucose metabolism
Scientific Title
Effect of beta-cryptoxanthin on the glucose metabolism in diabetic patients (chronic phase)
Scientific Title:Acronym
Chronic effect of beta-cryptoxanthin on the glucose metabolism
Region
| Japan |
Condition
Condition
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 type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of insulin resistance(HOMA-IR)and insulin secretion(HOMA-beta)
Key secondary outcomes
1.Changes in the physical findings(Body weight/waist circumference/Blood pressure/
Heart rate/The body composition by impedance method)
2. change of glycemic state(FPG, HbA1C)
3.Change og liver function (AST ALT GTP)
4.Change ofLipid metabolism(TC, HDL-C, TG, sdLDL)
5.Safety and adverse events
6.Change of Renal function (eGFR)
7.Change of oxidative stress marker (U-8OHDG)
8.Changes in blood cytokine (Adiponectin)
9. Dietary intake-ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
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.HbA1C<8.0% within 8 weeks before the start of test
2.treated with diet and exercise or oral hypoglycemic agents for 12 weeks or longer
3.Outpatient
4. That drinking fruit juice of 16 weeks or more are possible
Key exclusion criteria
1.hypersensitivity to components of the juice
2.history of type 1 diabetes or glucose intolerance and gestational diabetes
3.history of ketoacidosis
4.history of hypoglycemia severe symptoms associated with loss of consciousness or coma
5.poorly controlled diabetes
6. poorly controlled hypertension, systolic blood pressure >160 mmHg, or diastolic blood pressure >100
7.patients with grade 3 or more of the Ministry of Health, Labour and Welfare drug side effects classification serious complication
8.pregnancy or breast feeding
9.inability to participate in the study as assessed by the investigators
Target sample size
40
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
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, Kanazawa University
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=R000014225
