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Metabolic Syndrome and Fingertip Endothelial Dysfunction

NCT ID: NCT01007227

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-12-31

Brief Summary

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Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).

Detailed Description

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Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle instruction

Group Type OTHER

Lifestyle instruction

Intervention Type OTHER

Instruction dietetic and exercise therapy

Interventions

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Lifestyle instruction

Instruction dietetic and exercise therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)

Exclusion Criteria

* Severe valvular heart disease
* Atrial septal defect
* Myocarditis
* Cardiomyopathy
* Active inflammatory diseases
* Pulmonary hypertension
* Chronic kidney disease on hemodialysis
* Advanced hepatic disease
* Leukemia
* Schizophrenia; AND
* Cerebrovascular disease and residual hemiplegia.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Seigo Sugiyama

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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743EndothelialMetsyd

Identifier Type: -

Identifier Source: org_study_id