UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011218 |
|---|---|
| Receipt number | R000011698 |
| Scientific Title | The effectiveness of Cholestimide on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2014/01/27 12:13:46 |
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Basic information
Public title
The effectiveness of Cholestimide
on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial
Acronym
The effectiveness of Cholestimide
on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial
Scientific Title
The effectiveness of Cholestimide
on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial
Scientific Title:Acronym
The effectiveness of Cholestimide
on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes, Dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of cholestimide on visceral fat, basal metablic rate and blood glucose in type 2 Diabetes, dyslipidemia patients with visceral fat accumulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
1. Resting energy expenditure, Respiratory quotient
2. HbA1c, blood glucose, Insulin secretion
3.lipid metabolism
4.oxidative stress
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Cholestimide 3g/day add on to statin for the first 24 weeks, then withdrawal of Cholestimide for the next 24 weeks
Interventions/Control_2
Administration of statin for the first 24 weeks, then add Cholestimide 3g/day for the next 24 weeks
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients whose body mass index(BMI) is above 25, Visceral fat area is above 100cm2, andHbA1c(NGSP) is above 6.5%
Patients who have dyslipidemia and administered by Atorvastatin , Pitavastatin or Rosuvastation at least for 2 months, and LDL-cholesterol is above 90 mg/dl
Key exclusion criteria
Patients with complete biliary obstruction
Patients with hypersensitivity to cholestimide or past history of ileus.
Patients with poor control of constipation
Patients who take warfarin, tetracycline, Phenobarbital, thyroid gland preparation, digitalis
Patients with unstable proliferative diabetic retinopathy
Patients whose stage of diabetic nephropathy is above stage 4
Patients who have active infection or are under treatment of malignancy
Patients who have macroangiopathy
Patients who are considered to be inadequate to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
uchigata@dmc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Risa Ide |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
fujimaki@dmc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Diabetes Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 18 | 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
| 2007 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 07 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 18 | Day |
Last modified on
| 2014 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011698
| 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 |
