UMIN-CTR Clinical Trial

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

metabolic syndrome

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

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

Email

h-takase@ken.ja-shizuoka.or.jp

Institute

Enshu Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

07

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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