UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Title of the study (Brief title)	Curcumin on IGT
Region	Japan

Condition
Condition	IGT
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to determine the beneficial effects of high-absorption curcumin with DDS (drug-delivery system) (Theracurmin) in patients with impaired glucose tolerance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	High-absorption curcumin with DDS (Theracurmin, 1 capsule: 30 mg) at a fixed daily dose of 6 capsules/day.
Interventions/Control_2	Placebo at a fixed daily dose of 6 capsules/day.
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	Patients with impaired glucose tolerance or type 2 diabetes, in whom HbA1c values between 6.3 and <8.4% (No history of insulin treatment within 1 year before registration)
Key exclusion criteria	1) insulin therapy 2) renal insufficiency (Cre >= 4.0mg/dL) or hemodialysis 3) severe hepatic disorder or liver chirrosis 4) Unstable angina pectoris, acute myocardial infarction, severe coronary heart disease (left main trunk or triple vessel disease) 5) Shock, Heart failure, myocardila infarction, Pulmonary embolism 6) Stroke within 3 months 7) Severe ketosis, diabetic coma or pre-coma 9) Malneutrition 10) Malignancy 11) Anemia 12) Steroid use
Target sample size	60

Research contact person
Name of lead principal investigator	Koji Hasegawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Translational Research
Address	1-1 Mukaihata-cho, Fukakusa, Fusimi-ku, Kyoto
TEL	075-641-9161
Email	koj@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Koji Hasegawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Translational Research
Address	Division of Translational Research
TEL	075-641-9161
Homepage URL
Email	koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute	National Hospital organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	Theravalues
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	2012 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 13 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 22 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008671