UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015714 |
|---|---|
| Receipt number | R000018261 |
| Scientific Title | Efficacy of Coenzyme Q10 in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled parallel-group comparative study |
| Date of disclosure of the study information | 2014/11/18 |
| Last modified on | 2014/11/18 13:41:51 |
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Basic information
Public title
Efficacy of Coenzyme Q10 in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled parallel-group comparative study
Acronym
Efficacy of Coenzyme Q10 in type 2 diabetes
Scientific Title
Efficacy of Coenzyme Q10 in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled parallel-group comparative study
Scientific Title:Acronym
Efficacy of Coenzyme Q10 in type 2 diabetes
Region
| Japan |
Condition
Condition
Japanese patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Coenzyme Q10 in blood glucose control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
Fasting blood glucose, insulin, glucagon, GA, 1,5 AG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
200mg Coenzyme Co10
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
6.1< HbA1c < 8.5
Key exclusion criteria
1. HbA1c > 8.5
2. Patients who have already taken
CoQ10.
3. Sever liver, kidney, heart disease
4. Allergic to CoQ10
5. Patients who have already enrolled in other clinical study within 3 months.
6. pregnant and nursing women
7. Inadequate who is judged by doctor
8. patients with insulin therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Graduate School of Medicine, Japan
Division name
Department of Clinical Cell Biology and Medicine,
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670
TEL
043-222-7171
Minoru.takemoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Hanaoka |
Organization
Chiba University Hospital
Division name
Clinical Research center
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677
TEL
043-222-7171
Homepage URL
http://www.chiba-crc.jp/index.html
shiken@office.chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Japan
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
千葉大学大学院医学研究院 Chiba University Graduate School of Medicine, Japan
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 18 | 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
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2014 | Year | 11 | Month | 18 | Day |
Last modified on
| 2014 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018261
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
