UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012059 |
|---|---|
| Receipt number | R000013944 |
| Scientific Title | Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance |
| Date of disclosure of the study information | 2013/10/21 |
| Last modified on | 2015/04/17 15:12:07 |
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Basic information
Public title
Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance
Acronym
Propolis, CO2 output, urine pH and insulin resistance
Scientific Title
Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance
Scientific Title:Acronym
Propolis, CO2 output, urine pH and insulin resistance
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 for acid output and 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
CO2 output, urine pH, HOMA-IR
Key secondary outcomes
fasting plasma glucose, HbA1c, serum insulin, blood ketone body, total cholesterol, HDL. LDL, triglyceride, remnant lile particle cholesterol(RLP-C), uric acid
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
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Brazilian Propolis(450.0mg/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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are able to give written informed consent
2) Age is over 35 years and less than 75 years
3) Type of practice: outpatient department
4) Patients are able to do the following things in this trial - getting good compliance with consuming investigational food and coming to hospital
Key exclusion criteria
1) Patients who did not agree with this study
2)Patients with severe renal dysfunction and severe hepatic dysfunction
3)Pregnant women, women who may be pregnant, and breast-feeding women
4)Patients treated with insulin
5)Patients judged by the investigator to be ineligible for some other reason
Target sample size
60
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
sayarinapm@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Fukuda |
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
+81-75-251-5506
Homepage URL
fukudatakuya0720@gmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Yamada Apiculture Center Inc. (Okayama, Japan)
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
| 2013 | Year | 10 | Month | 21 | 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
| 2013 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013944
| 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 |
