UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term intake experiment of D-psicose for type 2 diabetic patients
Title of the study (Brief title)	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	Koji murao
Organization	Kagawa University
Division name	department of endocrinology and metabolism
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	Koji murao
Organization	Kagawa University
Division name	department of endocrinology and metabolism
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031106