UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008479 |
|---|---|
| Receipt number | R000009966 |
| Scientific Title | Evaluation of the effect of Propolis on insulin resistance in patients with type 2 diabetes. |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2013/07/21 11:45:18 |
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Basic information
Public title
Evaluation of the effect of Propolis on insulin resistance in patients with type 2 diabetes.
Acronym
Evaluation of the effect of Propolis on insulin resistance in patients with type 2 diabetes.
Scientific Title
Evaluation of the effect of Propolis on insulin resistance in patients with type 2 diabetes.
Scientific Title:Acronym
Evaluation of the effect of Propolis on insulin resistance in patients with type 2 diabetes.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects of Propolis on insulin resistance in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HOMA-IR after 8 weeks of treatment
Key secondary outcomes
Changes in FPG,HbA1c,total cholesterol, HDL,LDL,triglyceride,serum insulin,remnant like particle cholesterol(RLP-C),HMW-adiponectin,TNF-alpha,high sensitive CRP,IL-6 and urine pH after 8 weeks of treatment.
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
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Brazilian Green Propolis (226.8mg/day)
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with written informed consent.
2) Aged over 30 years and under 80 years.
4) Type of practice: outpatient department.
5) Patients who will keep the rules to intake and to visit hospital.
Key exclusion criteria
1) Patients who did not agree with joining this study.
2)Patients with severe renal dysfunction or severe hepatic dysfunction.
3)Pregnant women, women who may be pregnant, and breast-feeding women.
4)Patients treated with insulin.
5)Patients who are ineligible for some other reason judged by attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Fukui |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
+81-75-251-5505
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
+81-75-251-5505
Homepage URL
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Institute for Bee Products & Health Science
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 20 | 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
The significant difference of HOMA-IR, HbA1c, blood sugar and insulin level were not observed in a propolis group and a placebo group. The significant decrease of triglyceride was obserbed in the propolis group.
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
| 2012 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 20 | Day |
Last modified on
| 2013 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009966
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
