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Metabolic Syndrome and Fingertip Endothelial Dysfunction

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Lifestyle instruction
Sponsored by
Kumamoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kumamoto University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lifestyle instruction

Arm Description

Outcomes

Primary Outcome Measures

Endothelial function assessed by RH-PAT

Secondary Outcome Measures

Metabolic status including waist circumference

Full Information

First Posted
November 2, 2009
Last Updated
September 25, 2013
Sponsor
Kumamoto University
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1. Study Identification

Unique Protocol Identification Number
NCT01007227
Brief Title
Metabolic Syndrome and Fingertip Endothelial Dysfunction
Official Title
Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kumamoto University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle instruction
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Lifestyle instruction
Intervention Description
Instruction dietetic and exercise therapy
Primary Outcome Measure Information:
Title
Endothelial function assessed by RH-PAT
Time Frame
About 1 year later
Secondary Outcome Measure Information:
Title
Metabolic status including waist circumference
Time Frame
About 1 year later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

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Metabolic Syndrome and Fingertip Endothelial Dysfunction

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