UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007361 |
|---|---|
| Receipt number | R000008671 |
| Scientific Title | Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2019/02/26 15:50:18 |
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Basic information
Public title
Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Acronym
Curcumin on IGT
Scientific Title
Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koji Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fusimi-ku, Kyoto
TEL
075-641-9161
koj@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
Address
Division of Translational Research
TEL
075-641-9161
Homepage URL
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital organization Kyoto Medical Center
Institute
Department
Personal name
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)
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
| 2012 | Year | 02 | Month | 22 | 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
| 2011 | Year | 12 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008671
