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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008479
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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