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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027143
Receipt No. R000031106
Scientific Title Long-term intake experiment of D-psicose for type 2 diabetic patients
Date of disclosure of the study information 2017/04/26
Last modified on 2018/10/31

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Basic information
Public title Long-term intake experiment of D-psicose for type 2 diabetic patients
Acronym Long-term intake experiment of D-psicose for type 2 diabetic patients
Scientific Title Long-term intake experiment of D-psicose for type 2 diabetic patients
Scientific Title:Acronym Long-term intake experiment of D-psicose for type 2 diabetic patients
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the safety of diabetic and cholesterol elevated persons when 5 g of D - psicose is continuously ingested for 12 months.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the fluctuation of the value of LDL-C before and after administration of D-psicose
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of the test product for 12 months
Interventions/Control_2
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 1.fasting blood glucose level 126 mg / dL or more or HbA 1 c (NGSP) 6.5% or more
2. LDL-C high price person (LDL-C 120 mg / dL or more and less than 160 mg / dL)
3. Persons who are taking medication for treating diabetes or who are administering insulin
Key exclusion criteria 1.Patients falling under D-psicose administration contraindications
2.Patients taking oral administration of HMG-CoA reductase inhibitor
3.Patients participating in other clinical trials
4.Pregnant women, maternity women, lactating women or women with the possibility of pregnancy
5.Patients who have poor glycemic control with HbA1c> 8%
6.Patients who have severe renal dysfunction (serum creatinine value> 1.5 mg / dl)
7.Patients with other serious complications
8.Other patients judged inappropriate as judged by doctors
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji murao
Organization Kagawa University
Division name department of endocrinology and metabolism
Zip code
Address 1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL 087-891-2230
Email labmed@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji murao
Organization Kagawa University
Division name department of endocrinology and metabolism
Zip code
Address 1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL 087-891-2230
Homepage URL
Email labmed@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Matsutani Chemical Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit 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
2017 Year 04 Month 26 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 Completed
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 07 Day
Last follow-up date
2018 Year 09 Month 13 Day
Date of closure to data entry
2018 Year 10 Month 31 Day
Date trial data considered complete
2018 Year 10 Month 31 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 26 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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