UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008548 |
|---|---|
| Receipt number | R000010047 |
| Scientific Title | Effects of ezetimibe on visceral fat in patients with metabolic syndrome: a randomized controlled study |
| Date of disclosure of the study information | 2012/07/27 |
| Last modified on | 2012/07/27 13:26:30 |
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Basic information
Public title
Effects of ezetimibe on visceral fat in patients with metabolic syndrome: a randomized controlled study
Acronym
Fat in METS
Scientific Title
Effects of ezetimibe on visceral fat in patients with metabolic syndrome: a randomized controlled study
Scientific Title:Acronym
Fat in METS
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The metabolic syndrome has become increasingly common worldwide in recent years. Although the metabolic syndrome consists of several metabolic abnormalities, visceral fat accumulation is considered to be a root abnormality of this syndrome. Thus, the main target of therapeutic approach in this syndrome is to reduce visceral fat. Although modification of life style is recommended to improve the metabolic syndrome, life style modification is hard to achieve and effective medical therapy is required in such patients.
Ezetimibe is a widely used antidyslipidaemic agent and selectively inhibits the intestinal uptake and absorption of dietary and biliary cholesterol through its binding to Niemann-Pick C1-like 1, a cholesterol transporter in the intestine. In addition to its cholesterol-lowering effect, ezetimibe reduces serum triglyceride levels, improves insulin resistance, and increases adiponectin levels. These pleiotropic effects of ezetimibe may be associated with a reduction in visceral fat accumulation. Therefore, the present study was designed to investigate whether ezetimibe reduces visceral fat in patients with metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in visceral fat on CT from baseline to 6 months after randomization
Key secondary outcomes
Changes in lipid profiles, glucose metabolism, body weight, waist circumference, subcutaneous fat, and improvement of hepatic steatosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This is a prospective and randomized study to assess the effect of ezetimibe on visceral fat in patients with metabolic syndrome. After baseline assessment, patients are instructed to modify their lifestyle and randomly assigned to receive either ezetimibe at 10 mg per day after breakfast (ezetimibe group) or nothing (control group) for 6 months.
Interventions/Control_2
This is a prospective and randomized study to assess the effect of ezetimibe on visceral fat in patients with metabolic syndrome. After baseline assessment, patients are instructed to modify their lifestyle and randomly assigned to receive either ezetimibe at 10 mg per day after breakfast (ezetimibe group) or nothing (control group) for 6 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged >= 20 years with both metabolic syndrome and elevated low-density lipoprotein (LDL)-cholesterol levels (>= 120 mg/dL) were eligible for the present study if they were in a stable condition and any antihypertensive, antidyslipidaemic, and/or antidiabetic medications had not been changed for at least 4 weeks prior to the start of the study.
Key exclusion criteria
The exclusion criteria were: use of insulin, a history of hypersensitivity to ezetimibe, acute coronary syndrome and brain attacks (infarction or haemorrhage) within 3 months, secondary dyslipidaemia, familiar hypercholesterolaemia, pregnancy and severe hepatic, renal, active inflammatory and malignant diseases.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takase |
Organization
Enshu Hospital
Division name
Internal Medicine
Zip code
Address
1-1-1 Chuo, Naka-ku, Hamamatsu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Enshu Hospital
Division name
Internal Medicine
Zip code
Address
1-1-1 Chuo, Naka-ku, Hamamatsu
TEL
Homepage URL
h-takase@ken.ja-shizuoka.or.jp
Sponsor or person
Institute
Enshu Hospital
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 27 | 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
| 2008 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 27 | Day |
Last modified on
| 2012 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010047
