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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011218
Receipt No. 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

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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
Email 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
Email fujimaki@dmc.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, Diabetes Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011698

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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