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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003096
Receipt No. R000003753
Scientific Title Effect of statins on glucose metabolism in patients with diabetes mellitus
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/26

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Basic information
Public title Effect of statins on glucose metabolism in patients with diabetes mellitus
Acronym Effects of statins on glucose metabolism
Scientific Title Effect of statins on glucose metabolism in patients with diabetes mellitus
Scientific Title:Acronym Effects of statins on glucose metabolism
Region
Japan

Condition
Condition Hpercholesterolemic patients with impaired glucose tolerance or moderate type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficiency and safety of statins against glucose metabolism in hypercholesterolemic patients with impaired glucose tolerance or moderate type 2 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of influence on glucose metabolism among 3 groups and that of linkage between LDL-C and glucose metabolism
Key secondary outcomes 1) A change of influence on glucose metabolism
2) A change of LDL-C
3)Comparison of efficacy among 3 groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pravastatin 10mg daily for 6 months
Interventions/Control_2 Pitavastatin 2mg daily for 6 months
Interventions/Control_3 Pitavastatin 4mg daily for 6 months
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who
1)are at age of 18 to 80 years at time of consent, male or female
2)are impaired glucose tolerance by 75g oral glucose tolerance test (2-h plasma glucose 140-199 mg/dl)
3)are mild diabetes mellitus by HbA1c<7.0%
4)have Hypercholesterolemia with level of serum LDL-C>/= 140mg/dL(by Friedwald formula of by direct method in the case of patients with level of serum TG 400mg/dl)
5)provide written informed concent for participation in the study
Key exclusion criteria Patients who
1)have taken statins or are with the use of statins within 4 weeks
2)have severe hypertension (SBP>= 160 mmHg or DB` >= 100 mmHg)
3)have uncontrolled glucose metabolism(change of Hba1c >2%)
4)are judged as being inappropriate for this study by their own doctors
5)are judged as being inappropriate for this study by investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University
Division name Frontier Science Organization
Zip code
Address
TEL 076-234-4207
Homepage URL
Email tota@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 金沢大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 01 Month 26 Day
Last modified on
2010 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003753

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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