Metabolic Syndrome and Fingertip Endothelial Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007227
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : September 26, 2013
Information provided by (Responsible Party):
Seigo Sugiyama, 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).

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Lifestyle instruction Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome
Study Start Date : August 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Lifestyle instruction Other: Lifestyle instruction
Instruction dietetic and exercise therapy

Primary Outcome Measures :
  1. Endothelial function assessed by RH-PAT [ Time Frame: About 1 year later ]

Secondary Outcome Measures :
  1. Metabolic status including waist circumference [ Time Frame: About 1 year later ]

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007227

Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University

Responsible Party: Seigo Sugiyama, MD, PhD, Kumamoto University Identifier: NCT01007227     History of Changes
Other Study ID Numbers: 743EndothelialMetsyd
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases