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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012166
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email tota@staff.kanazawa-u.ac.jp

Sponsor
Institute Brain/Liver Interface Medicine Research
Center, Kanazawa University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014225


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