Metabolic Syndrome and Fingertip Endothelial Dysfunction

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Lifestyle instruction

• Registration Number: NCT01007227
• Lead Sponsor: Kumamoto University

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle instruction	Lifestyle instruction	-

Primary Outcome Measures

Name	Time	Method
Endothelial function assessed by RH-PAT	About 1 year later

Secondary Outcome Measures

Name	Time	Method
Metabolic status including waist circumference	About 1 year later

Trial Locations

Locations (1)

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan