UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003089 |
|---|---|
| Receipt number | R000002254 |
| Scientific Title | Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease |
| Date of disclosure of the study information | 2010/01/25 |
| Last modified on | 2014/04/24 12:04:09 |
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Basic information
Public title
Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Acronym
Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Scientific Title
Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Scientific Title:Acronym
Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes and peripheral arterial disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of beraprost sodium on improvement of insulin resistance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose infusion rate on euglycemic hyperinsulinemic clamp (0, 12 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral beraprost sodium for 12 weeks for patients with type 2 diabetes and peripheral arterial disease
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
HbA1c<8%
BMI>=25 or "Male Waist>=85cm or Female Waist>=90cm"
with untreated peripheral arterial disease
Key exclusion criteria
- Patients with bleeding tendancy
- Patients with severe renal dysfunction
- Patients with liver dysfunction
- Patients with a past hystory of drug hypersensitivity
- Pregnant women or women with breast-feeding
- Patients who took prostaglandin derivatives within 3 months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Kubota |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Metabolic Diseases
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8818
nkubota-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayuki Katsuyama |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Metabolic Diseases
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo, Japan
TEL
03-5800-8818
Homepage URL
katsuyama-hs@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Department of Metabolic Diseases
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding 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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s13340-014-0169-8
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
| 2009 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 25 | Day |
Last modified on
| 2014 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002254
